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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02180867
Other study ID # NCI-2014-01340
Secondary ID NCI-2014-01340AR
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date July 11, 2014
Est. completion date December 22, 2024

Study information

Verified date December 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 140
Est. completion date December 22, 2024
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Alveolar Soft Part Sarcoma
  • Angiomatoid Fibrous Histiocytoma
  • Atypical Fibroxanthoma
  • Chondrosarcoma
  • Clear Cell Sarcoma of Soft Tissue
  • Epithelioid Malignant Peripheral Nerve Sheath Tumor
  • Epithelioid Sarcoma
  • Extraskeletal Myxoid Chondrosarcoma
  • Extraskeletal Osteosarcoma
  • Fibrohistiocytic Neoplasm
  • Fibrosarcoma
  • Histiocytoma
  • Histiocytoma, Malignant Fibrous
  • Inflammatory Myofibroblastic Tumor
  • Intimal Sarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Liver Embryonal Sarcoma
  • Low Grade Fibromyxoid Sarcoma
  • Malignant Cutaneous Granular Cell Tumor
  • Malignant Peripheral Nerve Sheath Tumor
  • Malignant Triton Tumor
  • Mesenchymal Chondrosarcoma
  • Myxofibrosarcoma
  • Myxoid Chondrosarcoma
  • Myxoinflammatory Fibroblastic Sarcoma
  • Neoplasms
  • Nerve Sheath Neoplasm
  • Nerve Sheath Neoplasms
  • Osteosarcoma
  • PEComa
  • Pericytic Neoplasm
  • Plexiform Fibrohistiocytic Tumor
  • Sarcoma
  • Sarcoma, Alveolar Soft Part
  • Sarcoma, Clear Cell
  • Sarcoma, Synovial
  • Sclerosing Epithelioid Fibrosarcoma
  • Skin Glomus Tumor
  • Stage IB Soft Tissue Sarcoma AJCC v7
  • Stage IIB Soft Tissue Sarcoma AJCC v7
  • Stage III Soft Tissue Sarcoma AJCC v7
  • Stage IV Soft Tissue Sarcoma AJCC v7
  • Synovial Sarcoma
  • Undifferentiated High Grade Pleomorphic Sarcoma of Bone

Intervention

Drug:
Doxorubicin
Given IV
Doxorubicin Hydrochloride
Given IV
Ifosfamide
Given IV
Pazopanib
Given PO
Pazopanib Hydrochloride
Given PO
Radiation:
Radiation Therapy
Undergo radiation therapy
Procedure:
Therapeutic Conventional Surgery
Undergo surgery

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada McMaster Children's Hospital at Hamilton Health Sciences Hamilton Ontario
Canada Children's Hospital London Ontario
Canada Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec
Canada CHUM - Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada CHUM - Hopital Notre-Dame Montreal Quebec
Canada CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal Quebec
Canada The Montreal Children's Hospital of the MUHC Montreal Quebec
Canada CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Janeway Child Health Centre Saint John's Newfoundland and Labrador
Canada Hospital for Sick Children Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada CancerCare Manitoba Winnipeg Manitoba
Puerto Rico San Jorge Children's Hospital San Juan
Puerto Rico University Pediatric Hospital San Juan
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Children's Hospital Medical Center of Akron Akron Ohio
United States Albany Medical Center Albany New York
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Kaiser Permanente-Anaheim Anaheim California
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States C S Mott Children's Hospital Ann Arbor Michigan
United States Mission Hospital Asheville North Carolina
United States Children's Healthcare of Atlanta - Egleston Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Children's Hospital Colorado Aurora Colorado
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Dell Children's Medical Center of Central Texas Austin Texas
United States AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Bronson Battle Creek Battle Creek Michigan
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Saint Charles Health System Bend Oregon
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Walter Reed National Military Medical Center Bethesda Maryland
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Children's Hospital of Alabama Birmingham Alabama
United States The Kirklin Clinic at Acton Road Birmingham Alabama
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Providence Regional Cancer System-Centralia Centralia Washington
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States University of Virginia Cancer Center Charlottesville Virginia
United States T C Thompson Children's Hospital Chattanooga Tennessee
United States Lurie Children's Hospital-Chicago Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Oncology Hematology Care Inc-Blue Ash Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Rainbow Babies and Childrens Hospital Cleveland Ohio
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States Columbia Regional Columbia Missouri
United States Prisma Health Richland Hospital Columbia South Carolina
United States Nationwide Children's Hospital Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Bay Area Hospital Coos Bay Oregon
United States Driscoll Children's Hospital Corpus Christi Texas
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Medical City Dallas Hospital Dallas Texas
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Children's Hospital Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
United States Blank Children's Hospital Des Moines Iowa
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Kaiser Permanente Downey Medical Center Downey California
United States City of Hope Comprehensive Cancer Center Duarte California
United States Essentia Health Cancer Center Duluth Minnesota
United States Duke University Medical Center Durham North Carolina
United States Michigan State University Clinical Center East Lansing Michigan
United States El Paso Children's Hospital El Paso Texas
United States Newman Regional Health Emporia Kansas
United States Providence Regional Cancer Partnership Everett Washington
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center Fargo North Dakota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Poudre Valley Hospital Fort Collins Colorado
United States Golisano Children's Hospital of Southwest Florida Fort Myers Florida
United States Cook Children's Medical Center Fort Worth Texas
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Saint Catherine Hospital Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Glens Falls Hospital Glens Falls New York
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan
United States Spectrum Health at Butterworth Campus Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Saint Rose Ambulatory and Surgery Center Great Bend Kansas
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States BI-LO Charities Children's Cancer Center Greenville South Carolina
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States East Carolina University Greenville North Carolina
United States Greenville Health System Cancer Institute-Andrews Greenville South Carolina
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Connecticut Children's Medical Center Hartford Connecticut
United States HaysMed University of Kansas Health System Hays Kansas
United States Penn State Children's Hospital Hershey Pennsylvania
United States Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States Riley Hospital for Children Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic-Jacksonville Jacksonville Florida
United States Freeman Health System Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Children's Mercy Hospitals and Clinics Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States East Tennessee Childrens Hospital Knoxville Tennessee
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Sparrow Hospital Lansing Michigan
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Arkansas Children's Hospital Little Rock Arkansas
United States Loma Linda University Medical Center Loma Linda California
United States Miller Children's and Women's Hospital Long Beach Long Beach California
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Children's Hospital Los Angeles Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Los Angeles General Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Norton Children's Hospital Louisville Kentucky
United States Norton Hospital Pavilion and Medical Campus Louisville Kentucky
United States Norton Suburban Hospital and Medical Campus Louisville Kentucky
United States Covenant Children's Hospital Lubbock Texas
United States Texas Tech University Health Sciences Center-Lubbock Lubbock Texas
United States UMC Cancer Center / UMC Health System Lubbock Texas
United States Valley Children's Hospital Madera California
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Matthews Radiation Oncology Center Matthews North Carolina
United States Loyola University Medical Center Maywood Illinois
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Banner Children's at Desert Mesa Arizona
United States Nicklaus Children's Hospital Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Children's Hospital of Wisconsin Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States NYU Winthrop Hospital Mineola New York
United States Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota
United States University of Minnesota/Masonic Cancer Center Minneapolis Minnesota
United States West Virginia University Healthcare Morgantown West Virginia
United States Morristown Medical Center Morristown New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States The Children's Hospital at TriStar Centennial Nashville Tennessee
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Saint Peter's University Hospital New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park New York
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Children's Hospital New Orleans New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Mount Sinai Hospital New York New York
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Newark Beth Israel Medical Center Newark New Jersey
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Children's Hospital of The King's Daughters Norfolk Virginia
United States Advocate Children's Hospital-Oak Lawn Oak Lawn Illinois
United States Kaiser Permanente-Oakland Oakland California
United States UCSF Benioff Children's Hospital Oakland Oakland California
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Children's Hospital and Medical Center of Omaha Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Children's Hospital of Orange County Orange California
United States AdventHealth Orlando Orlando Florida
United States Nemours Children's Hospital Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Lucile Packard Children's Hospital Stanford University Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Advocate Children's Hospital-Park Ridge Park Ridge Illinois
United States Saint Joseph's Regional Medical Center Paterson New Jersey
United States Nemours Children's Clinic - Pensacola Pensacola Florida
United States Saint Jude Midwest Affiliate Peoria Illinois
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Drexel University School of Medicine Philadelphia Pennsylvania
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Saint Christopher's Hospital for Children Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Phoenix Childrens Hospital Phoenix Arizona
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania
United States Legacy Emanuel Children's Hospital Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Corewell Health Reed City Hospital Reed City Michigan
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Reid Health Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States Carilion Children's Roanoke Virginia
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Beaumont Children's Hospital-Royal Oak Royal Oak Michigan
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Lakeland Medical Center Saint Joseph Saint Joseph Michigan
United States Cardinal Glennon Children's Medical Center Saint Louis Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States Primary Children's Hospital Salt Lake City Utah
United States Children's Hospital of San Antonio San Antonio Texas
United States Methodist Children's Hospital of South Texas San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente-San Diego Zion San Diego California
United States Rady Children's Hospital - San Diego San Diego California
United States UCSF Medical Center-Mission Bay San Francisco California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Children's Cancer Program Scarborough Maine
United States Kaiser Permanente Washington Seattle Washington
United States Seattle Children's Hospital Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States South Jordan Health Center South Jordan Utah
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Saint John's Hospital Springfield Illinois
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Aurora Medical Center in Summit Summit Wisconsin
United States State University of New York Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Moffitt Cancer Center Tampa Florida
United States Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida
United States Scott and White Memorial Hospital Temple Texas
United States ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Banner University Medical Center - Tucson Tucson Arizona
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States New York Medical College Valhalla New York
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Children's National Medical Center Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Aurora Cancer Care-Waukesha Waukesha Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Methodist West Hospital West Des Moines Iowa
United States Saint Mary's Hospital West Palm Beach Florida
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Alfred I duPont Hospital for Children Wilmington Delaware
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Wright-Patterson Medical Center Wright-Patterson Air Force Base Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Relative Frequency of Actionable Mutations Descriptive statistical analyses will be provided to estimate the relative frequency of actionable mutations across the whole cohort and within more common histological subtypes, like synovial sarcoma and malignant peripheral nerve sheath tumors. At diagnosis
Other Prevalence of Circulating Tumor DNA (ctDNA) Descriptive analyses will be performed to summarize the prevalence of ctDNA. At diagnosis
Other Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib Pharmacokinetic parameters such as the clearance of doxorubicin and pazopanib will be estimated. Up to 48 hours after the end of infusion
Other Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax) To evaluate change in FDG 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. From enrollment to week 10 or 13 prior to tumor resection
Other Relative Risk of Failure Based on Both Standard Imaging and Pathologic Assessment To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, event free survival, and overall survival. From enrollment up to 60 months
Primary 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. After the first 6 weeks of Induction
Primary 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. After the first 6 weeks of Induction
Primary 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. Week 13 after induction
Primary 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. Week 10 after induction
Primary 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. From enrollment to up to 60 months
Secondary 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. From enrollment to up to 60 months
Secondary 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. From enrollment to up to 60 months
Secondary 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. From enrollment to up to 60 months
Secondary 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). Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
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