Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

Recruitment Status
ACTIVE, NOT RECRUITING - HAS RESULTS
(See Contacts and Locations)Verified November 2025 by National Cancer Institute (NCI)
Sponsor
National Cancer Institute (NCI)
Information Provided by (Responsible Party)
National Cancer Institute (NCI)
Clinicaltrials.gov Identifier
NCT02180867
Other Study ID Numbers:
NCI-2014-01340
First Submitted
June 30, 2014
First Posted
July 2, 2014
Results First Posted
June 23, 2020
Last Update Posted
April 12, 2026
Last Verified
November 2025

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

PRIMARY OBJECTIVES:

I. To identify the dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non rhabdomyosarcoma soft tissue sarcomas (NRSTS).

II. To compare the rates of near complete pathologic response (\> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable \> 5 cm, grade 2 or 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort.

III. To compare the rates of near complete pathologic response (\> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the phase III portion of the study).

IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed.

SECONDARY OBJECTIVES:

I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS.

II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS.

III. To define the toxicities of ifosfamide and doxorubicin chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

EXPLORATORY OBJECTIVES:

I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing.

II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome.

III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS.

IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.

V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival.

OUTLINE: This study starts as a dose-escalation study of pazopanib.

CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN A:

INDUCTION PHASE: Patients receive pazopanib orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16

REGIMEN B:

INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16.

NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN C:

INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.

REGIMEN D:

INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.

Condition or DiseaseIntervention/Treatment
Alveolar Soft Part SarcomaAngiomatoid Fibrous HistiocytomaAtypical FibroxanthomaClear Cell Sarcoma of Soft TissueEpithelioid Malignant Peripheral Nerve Sheath TumorEpithelioid SarcomaExtraskeletal Myxoid ChondrosarcomaExtraskeletal OsteosarcomaFibrohistiocytic NeoplasmFibrosarcomaInflammatory Myofibroblastic TumorIntimal SarcomaLeiomyosarcomaLiposarcomaLiver Embryonal SarcomaLow Grade Fibromyxoid SarcomaLow Grade Myofibroblastic SarcomaMalignant Peripheral Nerve Sheath TumorMalignant Skin Granular Cell TumorMalignant Triton TumorMesenchymal ChondrosarcomaMyxofibrosarcomaMyxoid ChondrosarcomaMyxoinflammatory Fibroblastic SarcomaNerve Sheath NeoplasmPEComaPericytic NeoplasmPlexiform Fibrohistiocytic TumorSclerosing Epithelioid FibrosarcomaSkin Glomus TumorStage IB Soft Tissue Sarcoma AJCC v7Stage IIB Soft Tissue Sarcoma AJCC v7Stage III Soft Tissue Sarcoma AJCC v7Stage IV Soft Tissue Sarcoma AJCC v7Synovial SarcomaUndifferentiated High Grade Pleomorphic Sarcoma of Bone
Drug: DoxorubicinDrug: DoxorubicinDrug: PazopanibRadiation: Radiation Therapy

Study Design

Study TypeInterventional
Actual Enrollment140 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitlePazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754)
Study Start DateJuly 10, 2014
Actual Primary Completion DateJune 29, 2019
Actual Study Completion Date7mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Regimen A (pazopanib, chemoradiation)
See Regimen A Detailed Description.
Drug: Doxorubicin
Given IV
Regimen B (chemoradiation)
See Regimen B Detailed Description.
Drug: Doxorubicin
Given IV
Regimen C (pazopanib, radiation therapy)
INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.
Drug: Pazopanib
Given PO
Regimen D (radiation therapy)
INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.
Radiation: Radiation Therapy
Undergo radiation therapy

Outcome Measures

Primary Outcome Measures
  1. Feasible Dose: Pediatric
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
  2. Feasible Dose: Adult
    The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and \< 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
  3. Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
    A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
  4. Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
    A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
  5. Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
    Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.
Secondary Outcome Measures
  1. Percentage of Patients Local Failure Free at 5 Years Following Study Entry
    Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
  2. Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
    Defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
  3. Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
    Defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
  4. Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
    Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Note: eligible patients must have a body surface area \>= 0.5 m\^2 AND be able to swallow whole tablets
Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:
Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials
Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and
Medically deemed able or unable to undergo chemotherapy
Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis
ELIGIBLE SITES:
Extremities: upper (including shoulder) and lower (including hip)
Trunk: body wall
INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis
ELIGIBILITY FOR CHEMOTHERAPY COHORT:
Stage T2a/b (\> 5 cm) and grade 2 or 3 AND
One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases):
Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified \[NOS\]")
Synovial sarcoma
Angiosarcoma of soft tissue
Adult fibrosarcoma
Mesenchymal (extraskeletal) chondrosarcoma
Leiomyosarcoma
Liposarcoma (excluding myxoid liposarcoma)
Undifferentiated pleomorphic sarcoma
Embryonal sarcoma of the liver
Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort
Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort:
Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") in patients \< 30 years of age
Synovial sarcoma
Embryonal sarcoma of the liver
ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:
Patients with any size of grade 2 or 3 of the following "intermediate (rarely metastasizing)" or "malignant" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort:
So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues
Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma
Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor
Chondro-osseous tumors - extraskeletal osteosarcoma
Pericytic (perivascular) tumors - malignant glomus tumor
Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor
Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma
Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study
Extent of disease:
Patients with non-metastatic and metastatic disease are eligible
Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor
Sufficient tissue and blood must be available to submit for required biology studies
Lansky performance status score \>= 70 for patients =\< 16 years of age
Karnofsky performance status score \>= 70 for patients \> 16 years of age
Absolute neutrophil count \>= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
Platelet count \>= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
Hemoglobin \>= 8 g/dL for patients =\< 16 years of age; \>= 9 g/dL for patients \> 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or normal serum creatinine based on age/gender as follows:
2 to \< 6 years; 0.8 mg/dL male; 0.8 mg/dL female
6 to \< 10 years; 1 mg/dL male; 1 mg/dL female
10 to \< 13 years; 1.2 mg/dL male; 1.2 mg/dL female
13 to \< 16 years; 1.5 mg/dL male; 1.4 mg/dL female
\>= 16 years; 1.5 mg/dL male; 1.4 mg/dL female
Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age
Shortening fraction of \>= 27% by echocardiogram OR ejection fraction of \>= 50% by radionuclide angiogram
Corrected QT interval (QTc) \< 480 msec
No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading \> 94% on room air if there is clinical indication for determination
Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio \[INR\]) are eligible
Patient must have a life expectancy of at least 3 months with appropriate therapy
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria
Patients with grade 1 NRSTS tumors of any size are not eligible
Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement
Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged \> 17 years with excess of 2.5 mL of hemoptysis are not eligible)
Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible
Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:
Patients aged =\< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication
Patients aged \> 17 years: systolic blood pressure \>= 140 mmHg and/or diastolic blood pressure \>= 90 mmHg that is not controlled by one anti-hypertensive medication
Prior Therapy:
Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy
Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)
Patients must have had no prior radiotherapy to tumor-involved sites
Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded
Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors
CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted
CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible
CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids)
Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible
Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:
Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills
Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
Active peptic ulcer disease
Malabsorption syndrome
Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:
Active peptic ulcer disease
Known intraluminal metastatic lesions
Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
Subjects with any of the following cardiovascular conditions within the past 6 months
Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Cardiac arrhythmia
Admission for unstable angina
Cardiac angioplasty or stenting
Coronary artery bypass graft surgery
Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
Arterial thrombosis
Symptomatic peripheral vascular disease
Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
History of serious or non-healing wound, ulcer, or bone fracture
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients who are unable to swallow whole tablets are not eligible
Patients with a body surface area \< 0.5 m\^2 are not eligible
Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy
Patients who are receiving any other investigational agent(s)
Pregnancy and breast feeding:
Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential

Contacts and Locations

Sponsors and CollaboratorsNational Cancer Institute (NCI)
Locations
Children's Hospital of Alabama | Birmingham Alabama, United States, 35233University of Alabama at Birmingham Cancer Center | Birmingham Alabama, United States, 35233The Kirklin Clinic at Acton Road | Birmingham Alabama, United States, 35243Anchorage Associates in Radiation Medicine | Anchorage Alaska, United States, 98508Alaska Breast Care and Surgery LLC | Anchorage Alaska, United States, 99508Alaska Oncology and Hematology LLC | Anchorage Alaska, United States, 99508Alaska Women's Cancer Care | Anchorage Alaska, United States, 99508Anchorage Oncology Centre | Anchorage Alaska, United States, 99508Katmai Oncology Group | Anchorage Alaska, United States, 99508Providence Alaska Medical Center | Anchorage Alaska, United States, 99508Banner Children's at Desert | Mesa Arizona, United States, 85202Phoenix Childrens Hospital | Phoenix Arizona, United States, 85016Banner University Medical Center - Tucson | Tucson Arizona, United States, 85719Arkansas Children's Hospital | Little Rock Arkansas, United States, 72202-3591Kaiser Permanente-Anaheim | Anaheim California, United States, 92806AIS Cancer Center at San Joaquin Community Hospital | Bakersfield California, United States, 93301Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank California, United States, 91505Kaiser Permanente Downey Medical Center | Downey California, United States, 90242City of Hope Comprehensive Cancer Center | Duarte California, United States, 91010Loma Linda University Medical Center | Loma Linda California, United States, 92354Miller Children's and Women's Hospital Long Beach | Long Beach California, United States, 90806Children's Hospital Los Angeles | Los Angeles California, United States, 90027Kaiser Permanente Los Angeles Medical Center | Los Angeles California, United States, 90027Los Angeles General Medical Center | Los Angeles California, United States, 90033USC / Norris Comprehensive Cancer Center | Los Angeles California, United States, 90033Cedars Sinai Medical Center | Los Angeles California, United States, 90048UCLA / Jonsson Comprehensive Cancer Center | Los Angeles California, United States, 90095Valley Children's Hospital | Madera California, United States, 93636UCSF Benioff Children's Hospital Oakland | Oakland California, United States, 94609Kaiser Permanente-Oakland | Oakland California, United States, 94611Children's Hospital of Orange County | Orange California, United States, 92868Lucile Packard Children's Hospital Stanford University | Palo Alto California, United States, 94304Stanford Cancer Institute Palo Alto | Palo Alto California, United States, 94304Kaiser Permanente-Riverside | Riverside California, United States, 92505Sutter Medical Center Sacramento | Sacramento California, United States, 95816University of California Davis Comprehensive Cancer Center | Sacramento California, United States, 95817Kaiser Permanente-San Diego Zion | San Diego California, United States, 92120Rady Children's Hospital - San Diego | San Diego California, United States, 92123UCSF Medical Center-Mission Bay | San Francisco California, United States, 94158Kaiser Permanente-San Marcos | San Marcos California, United States, 92078Kaiser San Rafael-Gallinas | San Rafael California, United States, 94903Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance California, United States, 90502Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee California, United States, 96161Children's Hospital Colorado | Aurora Colorado, United States, 80045UCHealth University of Colorado Hospital | Aurora Colorado, United States, 80045UCHealth Memorial Hospital Central | Colorado Springs Colorado, United States, 80909Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver Colorado, United States, 80218Poudre Valley Hospital | Fort Collins Colorado, United States, 80524Connecticut Children's Medical Center | Hartford Connecticut, United States, 06106Yale University | New Haven Connecticut, United States, 06520Alfred I duPont Hospital for Children | Wilmington Delaware, United States, 19803MedStar Georgetown University Hospital | Washington D.C. District of Columbia, United States, 20007Children's National Medical Center | Washington D.C. District of Columbia, United States, 20010UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach Florida, United States, 33442Golisano Children's Hospital of Southwest Florida | Fort Myers Florida, United States, 33908UF Health Cancer Institute - Gainesville | Gainesville Florida, United States, 32610Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood Florida, United States, 33021Nemours Children's Clinic-Jacksonville | Jacksonville Florida, United States, 32207University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami Florida, United States, 33136Nicklaus Children's Hospital | Miami Florida, United States, 33155AdventHealth Orlando | Orlando Florida, United States, 32803Nemours Children's Hospital | Orlando Florida, United States, 32827Nemours Children's Clinic - Pensacola | Pensacola Florida, United States, 32504Johns Hopkins All Children's Hospital | St. Petersburg Florida, United States, 33701Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa Florida, United States, 33607Moffitt Cancer Center | Tampa Florida, United States, 33612Saint Mary's Medical Center | West Palm Beach Florida, United States, 33407Emory University Hospital Midtown | Atlanta Georgia, United States, 30308Emory University Hospital/Winship Cancer Institute | Atlanta Georgia, United States, 30322Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta Georgia, United States, 30329Augusta University Medical Center | Augusta Georgia, United States, 30912Memorial Health University Medical Center | Savannah Georgia, United States, 31404Straub Clinic and Hospital | Honolulu Hawaii, United States, 96813Kaiser Permanente Moanalua Medical Center | Honolulu Hawaii, United States, 96819Kapiolani Medical Center for Women and Children | Honolulu Hawaii, United States, 96826Saint Luke's Cancer Institute - Boise | Boise Idaho, United States, 83712Saint Luke's Cancer Institute - Fruitland | Fruitland Idaho, United States, 83619Saint Luke's Cancer Institute - Meridian | Meridian Idaho, United States, 83642Saint Luke's Cancer Institute - Nampa | Nampa Idaho, United States, 83687Saint Luke's Cancer Institute - Twin Falls | Twin Falls Idaho, United States, 83301Lurie Children's Hospital-Chicago | Chicago Illinois, United States, 60611Northwestern University | Chicago Illinois, United States, 60611Rush MD Anderson Cancer Center | Chicago Illinois, United States, 60612University of Illinois | Chicago Illinois, United States, 60612University of Chicago Comprehensive Cancer Center | Chicago Illinois, United States, 60637Northwestern Medicine Cancer Center Delnor | Geneva Illinois, United States, 60134Loyola University Medical Center | Maywood Illinois, United States, 60153SSM Health Good Samaritan | Mount Vernon Illinois, United States, 62864UC Comprehensive Cancer Center at Silver Cross | New Lenox Illinois, United States, 60451Advocate Children's Hospital-Oak Lawn | Oak Lawn Illinois, United States, 60453Advocate Children's Hospital-Park Ridge | Park Ridge Illinois, United States, 60068Saint Jude Midwest Affiliate | Peoria Illinois, United States, 61637Saint John's Hospital | Springfield Illinois, United States, 62702Southern Illinois University School of Medicine | Springfield Illinois, United States, 62702Springfield Memorial Hospital | Springfield Illinois, United States, 62781Northwestern Medicine Cancer Center Warrenville | Warrenville Illinois, United States, 60555Riley Hospital for Children | Indianapolis Indiana, United States, 46202Ascension Saint Vincent Indianapolis Hospital | Indianapolis Indiana, United States, 46260Reid Health | Richmond Indiana, United States, 47374Blank Children's Hospital | Des Moines Iowa, United States, 50309Iowa Methodist Medical Center | Des Moines Iowa, United States, 50309UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines Iowa, United States, 50309Broadlawns Medical Center | Des Moines Iowa, United States, 50314Iowa Lutheran Hospital | Des Moines Iowa, United States, 50316University of Iowa/Holden Comprehensive Cancer Center | Iowa City Iowa, United States, 52242Siouxland Regional Cancer Center | Sioux City Iowa, United States, 51101Methodist West Hospital | West Des Moines Iowa, United States, 50266-7700Newman Regional Health | Emporia Kansas, United States, 66801Central Care Cancer Center - Garden City | Garden City Kansas, United States, 67846Saint Catherine Hospital | Garden City Kansas, United States, 67846Central Care Cancer Center - Great Bend | Great Bend Kansas, United States, 67530Saint Rose Ambulatory and Surgery Center | Great Bend Kansas, United States, 67530HaysMed | Hays Kansas, United States, 67601University of Kansas Cancer Center | Kansas City Kansas, United States, 66160The University of Kansas Cancer Center - Olathe | Olathe Kansas, United States, 66061University of Kansas Cancer Center-Overland Park | Overland Park Kansas, United States, 66210Mercy Hospital Pittsburg | Pittsburg Kansas, United States, 66762Salina Regional Health Center | Salina Kansas, United States, 67401University of Kansas Health System Saint Francis Campus | Topeka Kansas, United States, 66606University of Kansas Hospital-Westwood Cancer Center | Westwood Kansas, United States, 66205University of Kentucky/Markey Cancer Center | Lexington Kentucky, United States, 40536Norton Children's Hospital | Louisville Kentucky, United States, 40202Norton Hospital Pavilion and Medical Campus | Louisville Kentucky, United States, 40202Norton Suburban Hospital and Medical Campus | Louisville Kentucky, United States, 40207Children's Hospital New Orleans | New Orleans Louisiana, United States, 70118Ochsner Medical Center Jefferson | New Orleans Louisiana, United States, 70121Eastern Maine Medical Center | Bangor Maine, United States, 04401Maine Children's Cancer Program | Scarborough Maine, United States, 04074Sinai Hospital of Baltimore | Baltimore Maryland, United States, 21215Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore Maryland, United States, 21287Walter Reed National Military Medical Center | Bethesda Maryland, United States, 20889-5600Massachusetts General Hospital Cancer Center | Boston Massachusetts, United States, 02114Dana-Farber Cancer Institute | Boston Massachusetts, United States, 02215UMass Memorial Medical Center - University Campus | Worcester Massachusetts, United States, 01655C S Mott Children's Hospital | Ann Arbor Michigan, United States, 48109Bronson Battle Creek | Battle Creek Michigan, United States, 49017Henry Ford Cancer Institute-Downriver | Brownstown Michigan, United States, 48183Henry Ford Macomb Hospital-Clinton Township | Clinton Township Michigan, United States, 48038Wayne State University/Karmanos Cancer Institute | Detroit Michigan, United States, 48201Henry Ford Hospital | Detroit Michigan, United States, 48202Henry Ford Health Saint John Hospital | Detroit Michigan, United States, 48236Michigan State University | East Lansing Michigan, United States, 48823Hurley Medical Center | Flint Michigan, United States, 48503Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids Michigan, United States, 49503Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids Michigan, United States, 49503Trinity Health Grand Rapids Hospital | Grand Rapids Michigan, United States, 49503Allegiance Health | Jackson Michigan, United States, 49201Bronson Methodist Hospital | Kalamazoo Michigan, United States, 49007West Michigan Cancer Center | Kalamazoo Michigan, United States, 49007Beacon Kalamazoo | Kalamazoo Michigan, United States, 49048University of Michigan Health - Sparrow Lansing | Lansing Michigan, United States, 48912Trinity Health Muskegon Hospital | Muskegon Michigan, United States, 49444Corewell Health Lakeland Hospitals - Niles Hospital | Niles Michigan, United States, 49120Corewell Health Reed City Hospital | Reed City Michigan, United States, 49677Corewell Health Children's | Royal Oak Michigan, United States, 48073Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph Michigan, United States, 49085Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph Michigan, United States, 49085Munson Medical Center | Traverse City Michigan, United States, 49684Henry Ford West Bloomfield Hospital | West Bloomfield Michigan, United States, 48322Essentia Health Cancer Center | Duluth Minnesota, United States, 55805Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis Minnesota, United States, 55404University of Minnesota/Masonic Cancer Center | Minneapolis Minnesota, United States, 55455Mayo Clinic in Rochester | Rochester Minnesota, United States, 55905University of Mississippi Medical Center | Jackson Mississippi, United States, 39216Central Care Cancer Center - Bolivar | Bolivar Missouri, United States, 65613University of Missouri Children's Hospital | Columbia Missouri, United States, 65212Siteman Cancer Center at West County Hospital | Creve Coeur Missouri, United States, 63141Freeman Health System | Joplin Missouri, United States, 64804Children's Mercy Hospitals and Clinics | Kansas City Missouri, United States, 64108The University of Kansas Cancer Center-South | Kansas City Missouri, United States, 64131Research Medical Center | Kansas City Missouri, United States, 64132University of Kansas Cancer Center - North | Kansas City Missouri, United States, 64154University of Kansas Cancer Center - Lee's Summit | Lee's Summit Missouri, United States, 64064Mercy Clinic-Rolla-Cancer and Hematology | Rolla Missouri, United States, 65401Phelps Health Delbert Day Cancer Institute | Rolla Missouri, United States, 65401Mercy Hospital Springfield | Springfield Missouri, United States, 65804CoxHealth South Hospital | Springfield Missouri, United States, 65807Cardinal Glennon Children's Medical Center | St Louis Missouri, United States, 63104Washington University School of Medicine | St Louis Missouri, United States, 63110Mercy Hospital Saint Louis | St Louis Missouri, United States, 63141Children's Hospital and Medical Center of Omaha | Omaha Nebraska, United States, 68114University of Nebraska Medical Center | Omaha Nebraska, United States, 68198Oncology Las Vegas - Henderson | Henderson Nevada, United States, 89074Radiation Oncology Centers of Nevada Central | Las Vegas Nevada, United States, 89106Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas Nevada, United States, 89135Summerlin Hospital Medical Center | Las Vegas Nevada, United States, 89144Comprehensive Cancer Centers of Nevada | Las Vegas Nevada, United States, 89148Renown Regional Medical Center | Reno Nevada, United States, 89502Saint Mary's Regional Medical Center | Reno Nevada, United States, 89503Radiation Oncology Associates | Reno Nevada, United States, 89509Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon New Hampshire, United States, 03756Hackensack University Medical Center | Hackensack New Jersey, United States, 07601Morristown Medical Center | Morristown New Jersey, United States, 07960Saint Peter's University Hospital | New Brunswick New Jersey, United States, 08901Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick New Jersey, United States, 08903Newark Beth Israel Medical Center | Newark New Jersey, United States, 07112Saint Joseph's Regional Medical Center | Paterson New Jersey, United States, 07503University of New Mexico Cancer Center | Albuquerque New Mexico, United States, 87106Albany Medical Center | Albany New York, United States, 12208Roswell Park Cancer Institute | Buffalo New York, United States, 14263Glens Falls Hospital | Glens Falls New York, United States, 12801NYU Langone Hospital - Long Island | Mineola New York, United States, 11501The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park New York, United States, 11040Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York New York, United States, 10016Mount Sinai Hospital | New York New York, United States, 10029NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York New York, United States, 10032NYP/Weill Cornell Medical Center | New York New York, United States, 10065University of Rochester | Rochester New York, United States, 14642State University of New York Upstate Medical University | Syracuse New York, United States, 13210Montefiore Medical Center-Einstein Campus | The Bronx New York, United States, 10461Montefiore Medical Center-Weiler Hospital | The Bronx New York, United States, 10461Montefiore Medical Center - Moses Campus | The Bronx New York, United States, 10467New York Medical College | Valhalla New York, United States, 10595Mission Hospital | Asheville North Carolina, United States, 28801UNC Lineberger Comprehensive Cancer Center | Chapel Hill North Carolina, United States, 27599Carolinas Medical Center/Levine Cancer Institute | Charlotte North Carolina, United States, 28203Novant Health Presbyterian Medical Center | Charlotte North Carolina, United States, 28204Duke University Medical Center | Durham North Carolina, United States, 27710East Carolina University | Greenville North Carolina, United States, 27834Matthews Radiation Oncology Center | Matthews North Carolina, United States, 28105Wake Forest University Health Sciences | Winston-Salem North Carolina, United States, 27157Sanford Broadway Medical Center | Fargo North Dakota, United States, 58122Children's Hospital Medical Center of Akron | Akron Ohio, United States, 44308UHHS-Chagrin Highlands Medical Center | Beachwood Ohio, United States, 44122Indu and Raj Soin Medical Center | Beavercreek Ohio, United States, 45431Dayton Physicians LLC-Miami Valley South | Centerville Ohio, United States, 45459Miami Valley Hospital South | Centerville Ohio, United States, 45459Cincinnati Children's Hospital Medical Center | Cincinnati Ohio, United States, 45229Oncology Hematology Care Inc-Kenwood | Cincinnati Ohio, United States, 45236Oncology Hematology Care Inc-Blue Ash | Cincinnati Ohio, United States, 45242Case Western Reserve University | Cleveland Ohio, United States, 44106Rainbow Babies and Childrens Hospital | Cleveland Ohio, United States, 44106Cleveland Clinic Foundation | Cleveland Ohio, United States, 44195Nationwide Children's Hospital | Columbus Ohio, United States, 43205Ohio State University Comprehensive Cancer Center | Columbus Ohio, United States, 43210Dayton Children's Hospital | Dayton Ohio, United States, 45404Good Samaritan Hospital - Dayton | Dayton Ohio, United States, 45406Miami Valley Hospital | Dayton Ohio, United States, 45409Dayton Physician LLC - Englewood | Dayton Ohio, United States, 45415Miami Valley Hospital North | Dayton Ohio, United States, 45415Armes Family Cancer Center | Findlay Ohio, United States, 45840Blanchard Valley Hospital | Findlay Ohio, United States, 45840Orion Cancer Care | Findlay Ohio, United States, 45840Atrium Medical Center-Middletown Regional Hospital | Franklin Ohio, United States, 45005-1066Dayton Physicians LLC-Atrium | Franklin Ohio, United States, 45005Dayton Physicians LLC-Wayne | Greenville Ohio, United States, 45331Wayne Hospital | Greenville Ohio, United States, 45331Greater Dayton Cancer Center | Kettering Ohio, United States, 45409Kettering Medical Center | Kettering Ohio, United States, 45429Springfield Regional Cancer Center | Springfield Ohio, United States, 45504Springfield Regional Medical Center | Springfield Ohio, United States, 45504ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo Ohio, United States, 43606Dayton Physicians LLC - Troy | Troy Ohio, United States, 45373Upper Valley Medical Center | Troy Ohio, United States, 45373Wright-Patterson Medical Center | Wright-Patterson Air Force Base Ohio, United States, 45433University of Oklahoma Health Sciences Center | Oklahoma City Oklahoma, United States, 73104Mercy Hospital Oklahoma City | Oklahoma City Oklahoma, United States, 73120Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa Oklahoma, United States, 74146Saint Charles Health System | Bend Oregon, United States, 97701Clackamas Radiation Oncology Center | Clackamas Oregon, United States, 97015Bay Area Hospital | Coos Bay Oregon, United States, 97420Providence Portland Medical Center | Portland Oregon, United States, 97213Providence Saint Vincent Medical Center | Portland Oregon, United States, 97225Legacy Emanuel Children's Hospital | Portland Oregon, United States, 97227Oregon Health and Science University | Portland Oregon, United States, 97239Lehigh Valley Hospital-Cedar Crest | Allentown Pennsylvania, United States, 18103Lehigh Valley Hospital - Muhlenberg | Bethlehem Pennsylvania, United States, 18017Geisinger Medical Center | Danville Pennsylvania, United States, 17822Penn State Children's Hospital | Hershey Pennsylvania, United States, 17033Drexel University School of Medicine | Philadelphia Pennsylvania, United States, 19102Children's Hospital of Philadelphia | Philadelphia Pennsylvania, United States, 19104Thomas Jefferson University Hospital | Philadelphia Pennsylvania, United States, 19107Fox Chase Cancer Center | Philadelphia Pennsylvania, United States, 19111Saint Christopher's Hospital for Children | Philadelphia Pennsylvania, United States, 19134Allegheny General Hospital | Pittsburgh Pennsylvania, United States, 15212Children's Hospital of Pittsburgh of UPMC | Pittsburgh Pennsylvania, United States, 15224Lankenau Medical Center | Wynnewood Pennsylvania, United States, 19096Rhode Island Hospital | Providence Rhode Island, United States, 02903Prisma Health Cancer Institute - Spartanburg | Boiling Springs South Carolina, United States, 29316Medical University of South Carolina | Charleston South Carolina, United States, 29425Prisma Health Richland Hospital | Columbia South Carolina, United States, 29203Greenville Health System Cancer Institute-Andrews | Greenville South Carolina, United States, 29601Saint Francis Hospital | Greenville South Carolina, United States, 29601BI-LO Charities Children's Cancer Center | Greenville South Carolina, United States, 29605Prisma Health Cancer Institute - Butternut | Greenville South Carolina, United States, 29605Prisma Health Cancer Institute - Faris | Greenville South Carolina, United States, 29605Prisma Health Greenville Memorial Hospital | Greenville South Carolina, United States, 29605Saint Francis Cancer Center | Greenville South Carolina, United States, 29607Prisma Health Cancer Institute - Eastside | Greenville South Carolina, United States, 29615Prisma Health Cancer Institute - Greer | Greer South Carolina, United States, 29650Prisma Health Cancer Institute - Seneca | Seneca South Carolina, United States, 29672Sanford USD Medical Center - Sioux Falls | Sioux Falls South Dakota, United States, 57117-5134T C Thompson Children's Hospital | Chattanooga Tennessee, United States, 37403East Tennessee Childrens Hospital | Knoxville Tennessee, United States, 37916Saint Jude Children's Research Hospital | Memphis Tennessee, United States, 38105The Children's Hospital at TriStar Centennial | Nashville Tennessee, United States, 37203Vanderbilt University/Ingram Cancer Center | Nashville Tennessee, United States, 37232Dell Children's Medical Center of Central Texas | Austin Texas, United States, 78723Driscoll Children's Hospital | Corpus Christi Texas, United States, 78411Medical City Dallas Hospital | Dallas Texas, United States, 75230Parkland Memorial Hospital | Dallas Texas, United States, 75235UT Southwestern/Simmons Cancer Center-Dallas | Dallas Texas, United States, 75390El Paso Children's Hospital | El Paso Texas, United States, 79905Cook Children's Medical Center | Fort Worth Texas, United States, 76104Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston Texas, United States, 77030M D Anderson Cancer Center | Houston Texas, United States, 77030Covenant Children's Hospital | Lubbock Texas, United States, 79410UMC Cancer Center / UMC Health System | Lubbock Texas, United States, 79415Texas Tech University Health Sciences Center-Lubbock | Lubbock Texas, United States, 79430Children's Hospital of San Antonio | San Antonio Texas, United States, 78207Methodist Children's Hospital of South Texas | San Antonio Texas, United States, 78229University of Texas Health Science Center at San Antonio | San Antonio Texas, United States, 78229Scott and White Memorial Hospital | Temple Texas, United States, 76508Huntsman Cancer Institute/University of Utah | Salt Lake City Utah, United States, 84112Primary Children's Hospital | Salt Lake City Utah, United States, 84113South Jordan Health Center | South Jordan Utah, United States, 84009Central Vermont Medical Center/National Life Cancer Treatment | Berlin Corners Vermont, United States, 05602University of Vermont Medical Center | Burlington Vermont, United States, 05401University of Vermont and State Agricultural College | Burlington Vermont, United States, 05405University of Virginia Cancer Center | Charlottesville Virginia, United States, 22908Inova Fairfax Hospital | Falls Church Virginia, United States, 22042Children's Hospital of The King's Daughters | Norfolk Virginia, United States, 23507VCU Massey Comprehensive Cancer Center | Richmond Virginia, United States, 23298Carilion Children's | Roanoke Virginia, United States, 24014Providence Regional Cancer System-Aberdeen | Aberdeen Washington, United States, 98520PeaceHealth Saint Joseph Medical Center | Bellingham Washington, United States, 98225Providence Regional Cancer System-Centralia | Centralia Washington, United States, 98531Providence Regional Cancer Partnership | Everett Washington, United States, 98201Swedish Cancer Institute-Issaquah | Issaquah Washington, United States, 98029Kadlec Clinic Hematology and Oncology | Kennewick Washington, United States, 99336Providence Regional Cancer System-Lacey | Lacey Washington, United States, 98503PeaceHealth Saint John Medical Center | Longview Washington, United States, 98632Seattle Children's Hospital | Seattle Washington, United States, 98105Swedish Medical Center-Ballard Campus | Seattle Washington, United States, 98107Kaiser Permanente Washington | Seattle Washington, United States, 98112Swedish Medical Center-First Hill | Seattle Washington, United States, 98122Providence Sacred Heart Medical Center and Children's Hospital | Spokane Washington, United States, 99204Madigan Army Medical Center | Tacoma Washington, United States, 98431PeaceHealth Southwest Medical Center | Vancouver Washington, United States, 98664Providence Saint Mary Regional Cancer Center | Walla Walla Washington, United States, 99362North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima Washington, United States, 98902West Virginia University Charleston Division | Charleston West Virginia, United States, 25304West Virginia University Healthcare | Morgantown West Virginia, United States, 26506Aurora Cancer Care-Southern Lakes VLCC | Burlington Wisconsin, United States, 53105Aurora Health Center-Fond du Lac | Fond du Lac Wisconsin, United States, 54937Aurora Health Care Germantown Health Center | Germantown Wisconsin, United States, 53022Aurora Cancer Care-Grafton | Grafton Wisconsin, United States, 53024Aurora BayCare Medical Center | Green Bay Wisconsin, United States, 54311Aurora Cancer Care-Kenosha South | Kenosha Wisconsin, United States, 53142University of Wisconsin Carbone Cancer Center - University Hospital | Madison Wisconsin, United States, 53792Aurora Bay Area Medical Group-Marinette | Marinette Wisconsin, United States, 54143Marshfield Medical Center-Marshfield | Marshfield Wisconsin, United States, 54449Aurora Cancer Care-Milwaukee | Milwaukee Wisconsin, United States, 53209Aurora Saint Luke's Medical Center | Milwaukee Wisconsin, United States, 53215Children's Hospital of Wisconsin | Milwaukee Wisconsin, United States, 53226Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Aurora Sinai Medical Center | Milwaukee Wisconsin, United States, 53233Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh Wisconsin, United States, 54904Aurora Cancer Care-Racine | Racine Wisconsin, United States, 53406Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan Wisconsin, United States, 53081Aurora Medical Center in Summit | Summit Wisconsin, United States, 53066Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers Wisconsin, United States, 54241Aurora Cancer Care-Waukesha | Waukesha Wisconsin, United States, 53188Aurora Cancer Care-Milwaukee West | Wauwatosa Wisconsin, United States, 53226Aurora West Allis Medical Center | West Allis Wisconsin, United States, 53227Cross Cancer Institute | Edmonton Alberta, Canada, T6G 1Z2British Columbia Children's Hospital | Vancouver British Columbia, Canada, V6H 3V4CancerCare Manitoba | Winnipeg Manitoba, Canada, R3E 0V9Janeway Child Health Centre | St. John's Newfoundland and Labrador, Canada, A1B 3V6IWK Health Centre | Halifax Nova Scotia, Canada, B3K 6R8McMaster Children's Hospital at Hamilton Health Sciences | Hamilton Ontario, Canada, L8N 3Z5Children's Hospital | London Ontario, Canada, N6A 5W9Hospital for Sick Children | Toronto Ontario, Canada, M5G 1X8CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal Quebec, Canada, H1T 2M4CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal Quebec, Canada, H2X 3E4The Montreal Children's Hospital of the MUHC | Montreal Quebec, Canada, H3H 1P3Centre Hospitalier Universitaire Sainte-Justine | Montreal Quebec, Canada, H3T 1C5Allan Blair Cancer Centre | Regina Saskatchewan, Canada, S4T 7T1CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Québec , Canada, G1V 4G2San Jorge Children's Hospital | San Juan , Puerto Rico, 00912University Pediatric Hospital | San Juan , Puerto Rico, 00926
Investigators
Principal Investigator: Aaron R Weiss, Children's Oncology Group
Study Documents (Full Text)
Documents provided by National Cancer Institute (NCI): Study Protocol and Statistical Analysis Plan  April 7, 2019