Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

NCT ID: NCT00346164

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 588 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-05
• Study Completion Date: 2022-03-31

Brief Summary

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. 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 or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed Description

PRIMARY OBJECTIVES:

I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).

II. Assess event-free and overall survival of patients treated with these regimens.

III. Assess the pattern of treatment failure in these patients.

SECONDARY OBJECTIVES:

I. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS.

II. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS.

III. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy.

IV. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients.

V. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients.

VI. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers.

VII. Compare the Pediatric Oncology Group (POG) and Fédération Nationale des Centres de Lutte Contre le Cancer (French Federation of Cancer Centers [FNCLCC]) pathologic grading systems to determine which better correlates with clinical outcomes.

OUTLINE: This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs no), status of prior surgery (resected vs unresected), grade of tumor (low vs high), and size of primary tumor (≤ 5 cm vs > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs metastatic), tumor size (≤ 5 cm vs > 5 cm), extent of resection of primary tumor (resected vs unresected), extent of resection of metastases (complete or microscopic residual vs gross residual), microscopic tumor margins (negative vs positive), and tumor grade (low vs high).

GROUP 1 (low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B.

REGIMEN A (observation only): Patients undergo observation only.

REGIMEN B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

GROUP 2 (intermediate risk [nonmetastatic, resected or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D.

REGIMEN C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

*NOTE: *Patients who receive brachytherapy will initiate radiotherapy in Week 1. If brachytherapy is administered, chemotherapy should begin within 2 weeks of completion of brachytherapy and the Weeks 1 and 19 doxorubicin should be given instead at Weeks 7 and 10.

REGIMEN D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Neoadjuvant chemoradiotherapy and surgery: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy**. Patients undergo surgical resection in week 13.

NOTE: **Patients with primary hepatic tumors do not receive radiotherapy in week 4.

Adjuvant chemotherapy with or without radiotherapy: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19***, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy.

NOTE: ***Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19.

GROUP 3 (high risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, and metastatic disease are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.

In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years.

Conditions

Adult Alveolar Soft-part Sarcoma; Adult Angiosarcoma; Adult Epithelioid Sarcoma; Adult Extraskeletal Chondrosarcoma; Adult Extraskeletal Osteosarcoma; Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Fibrous Histiocytoma; Adult Malignant Hemangiopericytoma; Adult Malignant Mesenchymoma; Adult Neurofibrosarcoma; Adult Synovial Sarcoma; Childhood Alveolar Soft-part Sarcoma; Childhood Angiosarcoma; Childhood Epithelioid Sarcoma; Childhood Fibrosarcoma; Childhood Leiomyosarcoma; Childhood Liposarcoma; Childhood Malignant Mesenchymoma; Childhood Neurofibrosarcoma; Childhood Synovial Sarcoma; Dermatofibrosarcoma Protuberans; Metastatic Childhood Soft Tissue Sarcoma; Nonmetastatic Childhood Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: No adjuvant treatment

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

Group Type: EXPERIMENTAL

clinical observation

Intervention Type: OTHER

Patients undergo observation

therapeutic conventional surgery

Intervention Type: PROCEDURE

Patients undergo surgery

Arm B: Low risk; adjuvant radiotherapy

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

Group Type: EXPERIMENTAL

clinical observation

Intervention Type: OTHER

Patients undergo observation

therapeutic conventional surgery

Intervention Type: PROCEDURE

Patients undergo surgery

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Patients undergo radiotherapy

Arm C: Intermediate & High risk; adjuvant chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

clinical observation

Intervention Type: OTHER

Patients undergo observation

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Patients undergo radiotherapy

ifosfamide

Intervention Type: DRUG

Given IV

Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

Group Type: EXPERIMENTAL

doxorubicin hydrochloride

Intervention Type: DRUG

Given IV

clinical observation

Intervention Type: OTHER

Patients undergo observation

therapeutic conventional surgery

Intervention Type: PROCEDURE

Patients undergo surgery

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

Patients undergo radiotherapy

ifosfamide

Intervention Type: DRUG

Given IV

Interventions

doxorubicin hydrochloride

Given IV

Intervention Type: DRUG

clinical observation

Patients undergo observation

Intervention Type: OTHER

therapeutic conventional surgery

Patients undergo surgery

Intervention Type: PROCEDURE

3-dimensional conformal radiation therapy

Patients undergo radiotherapy

Intervention Type: RADIATION

ifosfamide

Given IV

Intervention Type: DRUG

Other Intervention Names

ADM; ADR; Adria; Adriamycin PFS; Adriamycin RDF; observation; 3D conformal radiation therapy; 3D-CRT; Cyfos; Holoxan; IFF; IFX; IPP

Eligibility Criteria

Inclusion Criteria

• Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902

• Metastatic or non metastatic disease
• Meets 1 of the following criteria:

• Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:

• Adipocytic tumor, including liposarcoma of any of the following histology subtypes:

• Dedifferentiated
• Myxoid
• Round cell
• Pleomorphic type
• Mixed-type
• Not otherwise specified (NOS)
• Fibroblastic/myofibroblastic tumors, including any of the following:

• Solitary fibrous tumor
• Hemangiopericytoma
• Low-grade myofibroblastic sarcoma
• Myxoinflammatory fibroblastic sarcoma
• Adult fibrosarcoma*
• Myxofibrosarcoma
• Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor
• Sclerosing epithelioid fibrosarcoma
• So-called fibrohistiocytic tumors, including any of the following:

• Plexiform fibrohistiocytic tumor
• Giant cell tumor of soft tissues
• Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma
• Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells
• Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation
• Smooth muscle tumor (leiomyosarcoma)
• Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)
• Vascular tumor, including angiosarcoma
• Chondro-osseous tumors of any of the following types:

• Mesenchymal chondrosarcoma
• Extraskeletal osteosarcoma
• Tumors of uncertain differentiation, including any of the following:

• Angiomatoid fibrous histiocytoma
• Ossifying fibromyxoid tumor
• Myoepithelioma/parachordoma
• Synovial sarcoma
• Epithelioid sarcoma
• Alveolar soft-part sarcoma
• Clear cell sarcoma of soft tissue
• Extraskeletal myxoid chondrosarcoma ("chordoid type")
• Malignant mesenchymoma
• Neoplasms with perivascular epithelioid cell differentiation (PEComa)
• Clear cell myomelanocytic tumor
• Intimal sarcoma
• Malignant peripheral nerve sheath tumor
• Dermatofibrosarcoma protuberans meeting both of the following criteria:

• Non metastatic disease
• Tumor must be grossly resected prior to study enrollment
• Embryonal sarcoma of the liver
• Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)
• Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:

• Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection
• Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity
• High-grade tumor with metastases

• Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry
• Patients with a tumor recurrence after a gross total resection are not eligible
• Tumors arising in bone are not eligible
• Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.

• If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C)
• Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease)
• Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) OR Karnofsky PS 50-100% (for patients > 16 years of age)
• Life expectancy ≥ 3 months
• Absolute neutrophil count ≥ 1,000/mm³*
• Platelet count ≥ 100,000/mm³*
• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year of age)* or serum creatinine based on age and/or gender as follows:

• 0.4 mg/dL (1 month to < 6 months of age)
• 0.5 mg/dL (6 months to < 1 year of age)
• 0.6 mg/dL (1 year to < 2 years of age)
• 0.8 mg/dL (2 years to < 6 years of age)
• 1.0 mg/dL (6 years to < 10 years of age)
• 1.2 mg/dL (10 years to < 13 years of age)
• 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age)
• 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
• Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
• Shortening fraction ≥ 27% by echocardiogram* OR ejection fraction ≥ 50% by radionuclide angiogram*
• Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy)

• No nursing for ≥ 1 month after completion of study treatment in study regimens C or D
• Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
• Negative pregnancy test
• No evidence of dyspnea at rest*
• No exercise intolerance*
• Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)*
• Prior treatment for cancer allowed provided the patient meet the prior therapy requirements
• No prior anthracycline (e.g., doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D
• No prior radiotherapy to tumor-involved sites

• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheri Spunt, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

University of Arizona Health Sciences Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Children's Oncology Group

Arcadia, California, United States

Southern California Permanente Medical Group

Downey, California, United States

City of Hope Medical Center

Duarte, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Miller Children's Hospital

Long Beach, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Children's Hospital Central California

Madera, California, United States

Children's Hospital and Research Center at Oakland

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Childrens Hospital of Orange County

Orange, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

University of California San Francisco Medical Center-Parnassus

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center

Denver, Colorado, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Lee Memorial Health System

Fort Myers, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nemours Children's Clinic - Jacksonville

Jacksonville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Children's Hospital

Miami, Florida, United States

Baptist Hospital of Miami

Miami, Florida, United States

Florida Hospital

Orlando, Florida, United States

M D Anderson Cancer Center- Orlando

Orlando, Florida, United States

Nemours Childrens Clinic - Orlando

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

All Children's Hospital

St. Petersburg, Florida, United States

Saint Joseph Children's Hospital of Tampa

Tampa, Florida, United States

Saint Mary's Hospital

West Palm Beach, Florida, United States

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

University of Hawaii

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

University of Illinois

Chicago, Illinois, United States

Childrens Memorial Hospital

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Advocate Hope Children's Hospital

Oak Lawn, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Saint Jude Midwest Affiliate

Peoria, Illinois, United States

Southern Illinois University

Springfield, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Saint Vincent Hospital and Health Services

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kentucky

Lexington, Kentucky, United States

Kosair Children's Hospital

Louisville, Kentucky, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Maine Children's Cancer Program

Scarborough, Maine, United States

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Saint John Hospital and Medical Center

Detroit, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Kalamazoo Center for Medical Studies

Kalamazoo, Michigan, United States

Michigan State University - Breslin Cancer Center

Lansing, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Missouri-Columbia

Columbia, Missouri, United States

The Childrens Mercy Hospital

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Saint John's Mercy Medical Center

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Nevada Cancer Research Foundation CCOP

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

UMDNJ - Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Saint Joseph's Regional Medical Center

Paterson, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Albany Medical Center

Albany, New York, United States

Brooklyn Hospital Center

Brooklyn, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

The Steven and Alexandra Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

New York University Langone Medical Center

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

State University of New York Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

Mission Hospitals Inc

Asheville, North Carolina, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Presbyterian Hospital

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Medical Center-Fargo

Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Children's Medical Center of Dayton

Dayton, Ohio, United States

The Toledo Hospital/Toledo Children's Hospital

Toledo, Ohio, United States

Mercy Children's Hospital

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Legacy Emanuel Children's Hospital

Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center

Portland, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Palmetto Health Richland

Columbia, South Carolina, United States

Greenville Cancer Treatment Center

Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

T C Thompson Children's Hospital

Chattanooga, Tennessee, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Texas Tech University Health Science Center-Amarillo

Amarillo, Texas, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Driscoll Children's Hospital

Corpus Christi, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Covenant Children's Hospital

Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

University of Vermont

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Childrens Hospital-King's Daughters

Norfolk, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

Madigan Army Medical Center

Tacoma, Washington, United States

West Virginia University Charleston

Charleston, West Virginia, United States

Saint Vincent Hospital

Green Bay, Wisconsin, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Midwest Children's Cancer Center

Milwaukee, Wisconsin, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

The Children's Hospital at Westmead

Sydney, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Women's and Children's Hospital-Adelaide

North Adelaide, South Australia, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Princess Margaret Hospital for Children

Perth, Western Australia, Australia

Alberta Children's Hospital

Calgary, Alberta, Canada

University of Alberta Hospital

Edmonton, Alberta, Canada

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Janeway Child Health Centre

St. John's, Newfoundland and Labrador, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

Chedoke-McMaster Hospitals

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada

Hospital Sainte-Justine

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec

Ste-Foy, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Starship Children's Hospital

Grafton, Auckland, New Zealand

San Jorge Children's Hospital

Santurce, , Puerto Rico

Countries

United States; Australia; Canada; New Zealand; Puerto Rico

References

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Reference Type: DERIVED

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Venkatramani R, Xue W, Randall RL, Wolden S, Anderson J, Lopez-Terrada D, Black J, Kao SC, Shulkin B, Ostrenga A, Pappo A, Spunt SL. Synovial Sarcoma in Children, Adolescents, and Young Adults: A Report From the Children's Oncology Group ARST0332 Study. J Clin Oncol. 2021 Dec 10;39(35):3927-3937. doi: 10.1200/JCO.21.01628. Epub 2021 Oct 8.

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Million L, Hayes-Jordan A, Chi YY, Donaldson SS, Wolden S, Morris C, Terezakis S, Laurie F, Morano K, Fitzgerald TJ, Yock TI, Rodeberg DA, Anderson JR, Speights RA, Black JO, Coffin C, McCarville MB, Kao SC, Hawkins DS, Spunt SL, Randall RL. Local Control For High-Grade Nonrhabdomyosarcoma Soft Tissue Sarcoma Assigned to Radiation Therapy on ARST0332: A Report From the Childrens Oncology Group. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):821-830. doi: 10.1016/j.ijrobp.2021.01.051. Epub 2021 Feb 3.

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Reference Type: DERIVED

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Ferrari A, Chi YY, De Salvo GL, Orbach D, Brennan B, Randall RL, McCarville MB, Black JO, Alaggio R, Hawkins DS, Bisogno G, Spunt SL. Surgery alone is sufficient therapy for children and adolescents with low-risk synovial sarcoma: A joint analysis from the European paediatric soft tissue sarcoma Study Group and the Children's Oncology Group. Eur J Cancer. 2017 Jun;78:1-6. doi: 10.1016/j.ejca.2017.03.003. Epub 2017 Apr 7.

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Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Other Identifiers

NCI-2009-00426

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-ARST0332

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000483702

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA098543

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ARST0332

Identifier Type: -

Identifier Source: org_study_id