Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol

RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

Study Overview

• Status: Completed
• Conditions: Sarcoma
• Intervention / Treatment: Drug: cyclophosphamide; Radiation: radiation therapy; Drug: vincristine sulfate; Biological: filgrastim; Biological: sargramostim; Biological: dactinomycin

Detailed Description

OBJECTIVES:

• Determine the failure-free survival (FFS) rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy.
• Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy.
• Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments.
• Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens.

OUTLINE: Patients are assigned to 1 of 2 groups, depending on histology and site of disease.

• Group I (favorable tumor site, negative lymph nodes, stage 1, clinical group I, IIA, or III (orbit only), node negative [N0] OR unfavorable tumor site, negative or unknown lymph nodes, stage 2, clinical group I): Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every 12 weeks for 4 courses. Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8.
• Group II (favorable tumor site, positive lymph nodes, stage 1, clinical group III (orbit only), node positive [N1] OR favorable tumor site except orbit, any lymph nodes, stage 1, clinical group III OR unfavorable tumor site, stage 2, clinical group II OR unfavorable tumor site, stage 3, clinical group I or II): Patients receive vincristine and dactinomycin as in group I. Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover. Radiotherapy is administered on weeks 3-8, 12-17, or 28-33, if clinically indicated as in group I.

Patients are followed every 3-4 months for 3 years (4 years after diagnosis), every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 254 patients for group I will be accrued for this study within 6 years. Approximately 12 patients per year will be accrued for group II.

• Study Type: Interventional
• Enrollment (Actual): 483
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Sydney Children's Hospital
    • Westmead, New South Wales, Australia, 2145
      • Children's Hospital at Westmead
  • Queensland
    • Brisbane, Queensland, Australia, 4029
      • Royal Children's Hospital
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Women's and Children's Hospital
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Royal Children's Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6001
      • Princess Margaret Hospital for Children
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Alberta Children's Hospital
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3V4
      • British Columbia Children's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Janeway Children's Health and Rehabilitation Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 3G9
      • IWK Health Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster Children's Hospital at Hamilton Health Sciences
    • London, Ontario, Canada, N6C 2V5
      • Children's Hospital of Western Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • Hopital Sainte Justine
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Center - Montreal Children's Hospital
    • Sainte Foy, Quebec, Canada, GIV 4G2
      • Centre de Recherche du Centre Hospitalier de l'Universite Laval
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Allan Blair Cancer Centre at Pasqua Hospital
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Saskatoon Cancer Centre
• Netherlands
  • Groningen, Netherlands, 9700 RB
    • Academisch Ziekenhuis Groningen
• New Zealand
  • Auckland, New Zealand
    • Starship Children's Hospital
• Puerto Rico
  • San Juan, Puerto Rico, 00936-5067
    • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
  • Santurce, Puerto Rico, 00912
    • San Jorge Childrens Hospital
• Switzerland
  • Bern, Switzerland, CH 3010
    • Swiss Pediatric Oncology Group Bern
  • Geneva, Switzerland, CH 1211
    • Swiss Pediatric Oncology Group Geneva
  • Lausanne, Switzerland, CH 1011
    • Swiss Pediatric Oncology Group Lausanne
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham Comprehensive Cancer Center
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Cancer Research Institute
  • Arizona
    • Phoenix, Arizona, United States, 85016-7710
      • Phoenix Children'S Hospital
    • Tucson, Arizona, United States, 85724
      • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • California
    • Downey, California, United States, 90242
      • Southern California Permanente Medical Group
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center
    • La Jolla, California, United States, 92093-0658
      • Rebecca and John Moores UCSD Cancer Center
    • Loma Linda, California, United States, 92354
      • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    • Long Beach, California, United States, 90801-1428
      • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90095-1781
      • Jonsson Comprehensive Cancer Center, UCLA
    • Los Angeles, California, United States, 90027-0700
      • Children's Hospital Los Angeles
    • Madera, California, United States, 93638-8762
      • Children's Hospital Central California
    • Oakland, California, United States, 94609-1809
      • Children's Hospital and Research Center at Oakland
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital at Stanford University Medical Center
    • Sacramento, California, United States, 95816
      • Sutter Cancer center
    • Sacramento, California, United States, 95817
      • University of California Davis Cancer Center
    • Sacramento, California, United States, 95825
      • Kaiser Permanente Medical Center - Sacramento
    • San Diego, California, United States, 92120
      • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
    • San Diego, California, United States, 92123-4282
      • Children's Hospital and Health Center, San Diego
    • San Francisco, California, United States, 94115
      • UCSF Comprehensive Cancer Center
    • Santa Barbara, California, United States, 93102
      • Santa Barbara Cottage Hospital
    • Santa Clara, California, United States, 95051-5386
      • Kaiser Permanente Medical Center - Santa Clara
    • Travis Air Force Base, California, United States, 94535
      • David Grant Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218-1088
      • Children's Hospital of Denver
    • Denver, Colorado, United States, 80218
      • Presbyterian - St. Luke's Medical Center
  • Connecticut
    • Farmington, Connecticut, United States, 06360-7106
      • University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center
    • New Haven, Connecticut, United States, 06520-8028
      • Yale Comprehensive Cancer Center
  • Delaware
    • Wilmington, Delaware, United States, 19899
      • Alfred I. DuPont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Lombardi Cancer Center at Georgetown University Medical Center
    • Washington, District of Columbia, United States, 20010-2970
      • Children's National Medical Center
    • Washington, District of Columbia, United States, 20307-5001
      • Walter Reed Army Medical Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Fort Myers, Florida, United States, 33908
      • Children's Hospital of Southwest Florida
    • Gainesville, Florida, United States, 32610-0296
      • Shands Cancer Center at the University of Florida Health Science Center
    • Hollywood, Florida, United States, 33021
      • Joe DiMaggio Children's Hospital at Memorial
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Clinic
    • Miami, Florida, United States, 33176-2197
      • Baptist Hospital of Miami
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
    • Orlando, Florida, United States, 32806
      • Nemours Children's Clinic-Orlando
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Children's Hospital
    • St. Petersburg, Florida, United States, 33701
      • All Children's Hospital
    • Tampa, Florida, United States, 33677-4227
      • St. Joseph's Children's Hospital
    • West Palm Beach, Florida, United States, 33407
      • St. Mary's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
    • Augusta, Georgia, United States, 30912-4000
      • MBCCOP-Medical College of Georgia Cancer Center
    • Macon, Georgia, United States, 31201
      • Medical Center of Central Georgia
    • Savannah, Georgia, United States, 31405
      • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96859-5000
      • Tripler Army Medical Center
    • Honolulu, Hawaii, United States, 96813
      • Cancer Research Center of Hawaii
  • Idaho
    • Boise, Idaho, United States, 83712
      • Mountain States Tumor Institute - Boise
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital - Chicago
    • Chicago, Illinois, United States, 60601
      • University of Chicago Cancer Research Center
    • Chicago, Illinois, United States, 60612
      • University of Illinois Medical Center
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Hope Children's Hospital
    • Park Ridge, Illinois, United States, 60068-1174
      • Lutheran General Cancer Care Center
    • Peoria, Illinois, United States, 61637
      • Saint Jude Midwest Affiliate
    • Springfield, Illinois, United States, 62794-9658
      • Southern Illinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital and Health Care Center
    • Indianapolis, Indiana, United States, 46202-5225
      • Riley Children Cancer Center at Riley Hospital for Children
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Blank Children's Hospital
    • Iowa City, Iowa, United States, 52242-1009
      • Holden Comprehensive Cancer Center at University of Iowa
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0284
      • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Louisville, Kentucky, United States, 40202-3830
      • Kosair Children's Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
    • New Orleans, Louisiana, United States, 70118
      • Children's Hospital of New Orleans
    • New Orleans, Louisiana, United States, 70112
      • MBCCOP - LSU Health Sciences Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center at Tulane University Hospital and Clinic
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
    • Scarborough, Maine, United States, 04074-9308
      • Maine Children's Cancer Program
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Baltimore, Maryland, United States, 21225
      • Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21201-1595
      • Greenebaum Cancer Center at University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02111
      • Floating Hospital for Children
    • Springfield, Massachusetts, United States, 01107
      • Baystate Regional Cancer Program at Baystate Medical Center
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center - University Campus
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-0914
      • University of Michigan Comprehensive Cancer Center
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
    • Detroit, Michigan, United States, 48202
      • Josephine Ford Cancer Center at Henry Ford Hospital
    • Detroit, Michigan, United States, 48236
      • Van Elslander Cancer Center at St. John Hospital and Medical Center
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health and DeVos Children's Hospital
    • Kalamazoo, Michigan, United States, 49007-5364
      • Bronson Methodist Hospital
    • Lansing, Michigan, United States, 48910
      • Breslin Cancer Center at Ingham Regional Medical Center
    • Royal Oak, Michigan, United States, 48073-6769
      • William Beaumont Hospital - Royal Oak
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's - Duluth Clinic Cancer Center
    • Minneapolis, Minnesota, United States, 55404
      • Children's Hospitals and Clinics - Minneapolis
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center
    • Saint Paul, Minnesota, United States, 55102
      • Children's Hospitals and Clinics - Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
    • Saint Louis, Missouri, United States, 63104
      • Cardinal Glennon Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital of Omaha
    • Omaha, Nebraska, United States, 68198-2168
      • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital and Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Cancer Center at Hackensack University Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
    • Newark, New Jersey, United States, 07112-2094
      • Newark Beth Israel Medical Center
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Hospital and Medical Center
    • Summit, New Jersey, United States, 07901
      • Valerie Fund Children's Center at Atlantic Health
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Cancer Research and Treatment Center
  • New York
    • Albany, New York, United States, 12208
      • Cancer Center of Albany Medical Center
    • Bronx, New York, United States, 10461
      • Albert Einstein Clinical Cancer Center
    • Brooklyn, New York, United States, 11203
      • Suny Downstate Medical Center
    • Brooklyn, New York, United States, 11212
      • Brookdale University Hospital and Medical Center
    • Brooklyn, New York, United States, 11201-5493
      • Brooklyn Hospital Center
    • Brooklyn, New York, United States, 11219
      • Comprehensive Cancer Center at Maimonides Medical Center
    • Buffalo, New York, United States, 14263-0001
      • Roswell Park Cancer Institute
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11042
      • Schneider Children's Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan-Kettering Cancer Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10021
      • New York Weill Cornell Cancer Center at Cornell University
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center at Columbia University
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center at University of Rochester Medical Center
    • Stony Brook, New York, United States, 11794
      • Long Island Cancer Center at Stony Brook University Hospital
    • Syracuse, New York, United States, 13210
      • University Hospital at State University of New York - Upstate Medical University
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospitals
    • Chapel Hill, North Carolina, United States, 27599-7295
      • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Charlotte, North Carolina, United States, 28232-2861
      • Blumenthal Cancer Center at Carolinas Medical Center
    • Charlotte, North Carolina, United States, 28233
      • Presbyterian Healthcare
    • Durham, North Carolina, United States, 27710
      • Duke Comprehensive Cancer Center
    • Greenville, North Carolina, United States, 27858-4354
      • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
    • Winston-Salem, North Carolina, United States, 27157-1081
      • Comprehensive Cancer Center at Wake Forest University
  • North Dakota
    • Fargo, North Dakota, United States, 58103-4940
      • Dakota Cancer Institute at Innovis Health - Dakota Clinic
  • Ohio
    • Akron, Ohio, United States, 44308
      • Children's Hospital Medical Center of Akron
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44106-5065
      • Ireland Cancer Center
    • Columbus, Ohio, United States, 43205-2696
      • Children's Hospital of Columbus
    • Dayton, Ohio, United States, 45404
      • Children's Medical Center - Dayton
    • Toledo, Ohio, United States, 43601
      • Toledo Children's Hospital
    • Toledo, Ohio, United States, 43608
      • St. Vincent Mercy Medical Center
    • Youngstown, Ohio, United States, 44501
      • Forum Health-Tod Childrens Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Children's Hospital at Oklahoma University Medical Center
    • Tulsa, Oklahoma, United States, 74136
      • Natalie Warren Bryant Cancer Center
  • Oregon
    • Portland, Oregon, United States, 97225
      • CCOP - Columbia River Oncology Program
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital and Health Center & Children's Hospital
    • Portland, Oregon, United States, 97239-3098
      • Doernbecher Children's Hospital at Oregon Health & Science University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-1320
      • Geisinger Medical Center
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19134-1095
      • St. Christopher's Hospital for Children
    • Pittsburgh, Pennsylvania, United States, 15213-2583
      • Children's Hospital of Pittsburgh
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425-0721
      • Hollings Cancer Center at Medical University of South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health South Carolina Cancer Center
    • Greenville, South Carolina, United States, 29605
      • Children's Hospital of Greenville Hospital System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105-1080
      • Avera Cancer Institute
    • Sioux Falls, South Dakota, United States, 57117-5039
      • Sioux Valley Hospital at University of South Dakota Medical Center
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee State University Cancer Center at Johnson City Medical Center
    • Knoxville, Tennessee, United States, 37901
      • East Tennessee Children's Hospital
    • Memphis, Tennessee, United States, 38105-2794
      • St. Jude Children's Research Hospital
    • Nashville, Tennessee, United States, 37232-6310
      • Vanderbilt Children's Hospital
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Tech University Health Sciences Center School of Medicine
    • Austin, Texas, United States, 78701
      • Children's Hospital of Austin
    • Dallas, Texas, United States, 75230
      • Medical City Dallas Hospital
    • Dallas, Texas, United States, 75390-9063
      • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center - Fort Worth
    • Galveston, Texas, United States, 77555-0361
      • University of Texas Medical Branch
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030-4009
      • University of Texas - MD Anderson Cancer Center
    • Lackland Air Force Base, Texas, United States, 78236
      • San Antonio Military Pediatric Cancer and Blood Disorders Center
    • Lubbock, Texas, United States, 79410
      • Covenant Children's Hospital
    • San Antonio, Texas, United States, 78207
      • University of Texas Health Science Center at San Antonio
    • San Antonio, Texas, United States, 78229-3900
      • MBCCOP - South Texas Pediatrics
    • San Antonio, Texas, United States, 78229-3902
      • Methodist Cancer Center at Methodist Specialty and Transplant Hospital
    • Temple, Texas, United States, 76508
      • CCOP - Scott and White Hospital
    • Temple, Texas, United States, 76508
      • Center for Cancer Prevention and Care at Scott and White Clinic
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Burlington, Vermont, United States, 05401-3498
      • Vermont Cancer Center at University of Vermont
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Cancer Center at the University of Virginia
    • Falls Church, Virginia, United States, 22042-3300
      • Inova Fairfax Hospital
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters
    • Portsmouth, Virginia, United States, 23708-5100
      • Naval Medical Center, Portsmouth
    • Richmond, Virginia, United States, 23298-0121
      • Massey Cancer Center at Virginia Commonwealth University
    • Roanoke, Virginia, United States, 24029
      • Carilion Medical Center for Children
  • Washington
    • Seattle, Washington, United States, 98105
      • Children's Hospital and Regional Medical Center - Seattle
    • Seattle, Washington, United States, 98109-1024
      • Fred Hutchinson Cancer Research Center
    • Seattle, Washington, United States, 98112
      • Group Health Central Hospital
    • Spokane, Washington, United States, 99210-0248
      • Deaconess Medical Center
    • Tacoma, Washington, United States, 98431-5000
      • Madigan Army Medical Center
    • Tacoma, Washington, United States, 98415-0299
      • Mary Bridge Children's Hospital and Health Center
  • West Virginia
    • Charleston, West Virginia, United States, 25302
      • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
    • Huntington, West Virginia, United States, 25701
      • Cabell Huntington Hospital
    • Morgantown, West Virginia, United States, 26506-9300
      • West Virginia University Hospitals
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • CCOP - St. Vincent Hospital Cancer Center, Green Bay
    • Green Bay, Wisconsin, United States, 54301
      • Bellin Memorial Hospital
    • Green Bay, Wisconsin, United States, 54307-9070
      • St. Vincent Hospital
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin Comprehensive Cancer Center
    • Marshfield, Wisconsin, United States, 54449-5772
      • Marshfield Clinic
    • Marshfield, Wisconsin, United States, 54449
      • CCOP - Marshfield Clinic Research Foundation
    • Milwaukee, Wisconsin, United States, 53226
      • Midwest Children's Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 49 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed embryonal (EMB) rhabdomyosarcoma (RMS) or botryoid or spindle cell variants of EMB RMS or embryonal ectomesenchymoma meeting 1 of the following criteria:

  • Stage 1, no clinical group IV: Tumor in favorable site (orbit, head and neck [excluding parameningeal], genitourinary [not bladder/prostate], or biliary tract) and no metastatic disease
  • Stage 2 or 3, clinical group I or II: Tumor in unfavorable site (bladder/prostate, extremity, cranial parameningeal, trunk, retroperitoneum, pelvis, perineal/perianal, intrathoracic, gastrointestinal, or liver), no gross residual disease after initial surgery, and no metastatic disease
• Must have ipsilateral lymph node dissection if age 10 or over with primary paratesticular cancer OR under age 10 with clinically positive regional lymph nodes
• Low risk of recurrence
• Previously untreated disease
• No alveolar RMS or undifferentiated sarcoma
• No intermediate-risk disease
• No metastatic disease at diagnosis

PATIENT CHARACTERISTICS:

Age:

• Under 50

Performance status:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin elevation secondary to biliary or hepatic primaries allowed

Renal:

• Creatinine elevation secondary to tumor obstruction allowed

Other:

• No uncontrolled infection
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Failure-free survival

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• Malempati S, Rodeberg DA, Donaldson SS, Lyden ER, Anderson JR, Hawkins DS, Arndt CA. Rhabdomyosarcoma in infants younger than 1 year: a report from the Children's Oncology Group. Cancer. 2011 Aug 1;117(15):3493-501. doi: 10.1002/cncr.25887. Epub 2011 Jan 24.
• Walterhouse DO, Meza JL, Breneman JC, Donaldson SS, Hayes-Jordan A, Pappo AS, Arndt C, Raney RB, Meyer WH, Hawkins DS. Local control and outcome in children with localized vaginal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma committee of the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 15;57(1):76-83. doi: 10.1002/pbc.22928. Epub 2011 Feb 4.
• Breneman J, Meza J, Donaldson SS, Raney RB, Wolden S, Michalski J, Laurie F, Rodeberg DA, Meyer W, Walterhouse D, Hawkins DS. Local control with reduced-dose radiotherapy for low-risk rhabdomyosarcoma: a report from the Children's Oncology Group D9602 study. Int J Radiat Oncol Biol Phys. 2012 Jun 1;83(2):720-6. doi: 10.1016/j.ijrobp.2011.06.2011. Epub 2011 Nov 19.
• Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. doi: 10.1200/JCO.2010.30.4469. Epub 2011 Feb 28.

Study record dates

Study Major Dates

• Study Start: August 1, 1997
• Primary Completion (ACTUAL): September 1, 2006
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (ESTIMATE): January 27, 2003

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: adult malignant mesenchymoma; adult rhabdomyosarcoma; stage III adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage I adult soft tissue sarcoma; embryonal childhood rhabdomyosarcoma; embryonal-botryoid childhood rhabdomyosarcoma; previously untreated childhood rhabdomyosarcoma; nonmetastatic childhood soft tissue sarcoma; childhood malignant mesenchymoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Myosarcoma; Sarcoma; Rhabdomyosarcoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Vincristine; Sargramostim; Dactinomycin
• Other Study ID Numbers: D9602; COG-D9602 (OTHER: Children's Oncology Group); CCG-D9602 (OTHER: Children's Cancer Group); POG-D9602 (OTHER: Pediatric Oncology Group); IRS-D9602 (OTHER: Intergroup Rhabdosarcoma); CDR0000065542 (OTHER: Clinical Trials.gov)