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Spots Global Cancer Trial Database for Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

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Trial Identification

Brief Title: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Official Title: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Study ID: NCT00075582

Study Description

Brief Summary: This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy. SECONDARY OBJECTIVES: I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor. III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection. OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group. REGIMEN I (subset 1 patients) \[closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy\*\*, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. REGIMEN II (subset 2 patients)\[closed to accrual as of 9/23/2011\]: Patients receive VAC chemotherapy and radiotherapy\*\* as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin\* IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46. Patients with clinical group III disease may undergo second-look surgery at week 13 followed by response-adjusted radiotherapy, and continued VA\* chemotherapy. In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity. NOTE: \*For both regimens, dactinomycin is omitted during radiotherapy. NOTE: \*\*Clinical Group I tumors and those with Clinical Group III uterine/cervix primary disease with negative nodes who have undergone a complete resection (i.e. hysterectomy) at Week 13 do not receive radiotherapy at Week 13 Patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

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

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

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

UC Davis Comprehensive Cancer Center, Sacramento, 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

Children's National Medical Center, Washington, District of Columbia, United States

Broward Health Medical Center, Fort Lauderdale, 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

M D Anderson Cancer Center- Orlando, Orlando, Florida, United States

Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States

All Children's Hospital, Saint 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

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

Indiana University Medical Center, Indianapolis, Indiana, United States

Raymond Blank Children's Hospital, Des Moines, Iowa, 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

Children's Hospital-Main Campus, 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

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Baystate Medical Center, Springfield, Massachusetts, United States

C S Mott Children's Hospital, Ann Arbor, Michigan, United States

Wayne State University, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States

Michigan State University - Breslin Cancer Center, Lansing, Michigan, United States

William Beaumont Hospital, Royal Oak, 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

The Childrens Mercy Hospital, Kansas City, Missouri, United States

Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, 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

UMDNJ - Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

University of New Mexico Cancer Center, Albuquerque, New Mexico, United States

Albany Medical Center, Albany, New York, United States

Montefiore Medical Center, Bronx, 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

Mount Sinai Medical Center, New York, New York, United States

Columbia University Medical Center, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

University of Rochester, Rochester, New York, United States

State University of New York Upstate Medical University, Syracuse, 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

Presbyterian Hospital, Charlotte, North Carolina, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina, 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

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

Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Greenville Cancer Treatment Center, Greenville, South Carolina, 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

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

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

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

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

Sydney West Area Health Service-Westmead Hospital, Westmead, 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, Saint John's, Newfoundland and Labrador, 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

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Starship Children's Hospital, Grafton, Auckland, New Zealand

Christchurch Hospital, Christchurch, , New Zealand

San Jorge Children's Hospital, Santurce, , Puerto Rico

Swiss Pediatric Oncology Group - Geneva, Geneva, , Switzerland

Swiss Pediatric Oncology Group - Lausanne, Lausanne, , Switzerland

Contact Details

Name: David Walterhouse, MD

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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