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Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
This study has been completed.
First Received: November 1, 1999   Last Updated: September 24, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003958
  Purpose

RATIONALE: Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma.


Condition Intervention Phase
Sarcoma
 Biological: dactinomycin
Biological: filgrastim
Biological: sargramostim
Drug: cyclophosphamide
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Procedure: surgical procedure
Radiation: radiation therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate-Risk Rhabdomyosarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma Surgery
Drug Information available for: Cyclophosphamide Dactinomycin Vincristine Topotecan hydrochloride Filgrastim Sargramostim Topotecan Vincristine sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Early response rate (ERR) (i.e., complete response/partial response [CR/PR]) at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Failure-free survival (FFS) at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Survival at end of therapy & at 3, 5, and 10 yrs after completion of therapy [ Designated as safety issue: No ]
  • Acute and late effects (e.g., sterility, second malignancy, radiation effects, and growth effects) of these regimens continuously for up to 10 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of second-look surgery in patients with bulk residual tumor at diagnosis and those who become "tumor free" or have microscopic tumor only and are treated with reduced dose radiation at the end of therapy [ Designated as safety issue: No ]
  • Rate of local failure in selected patients with bulk residual tumors at diagnosis who undergo second-look resection and response-adjusted radiotherapy dose reduction ongoing for up to 10 years [ Designated as safety issue: No ]
  • Preoperative radiotherapy followed by second-look surgery indicated for patients who respond poorly to induction chemotherapy [ Designated as safety issue: No ]
  • Define and compare clinical features (demographics such as age, disease site and stage, node involvement, or outcome) of patient subgroups with alveolar rhabdomyosarcoma whose tumors carry t(2;13), t(1;13) or neither transloc. at end of the study [ Designated as safety issue: No ]
  • Estimation of ERR, FFS, and survival of patients with alveolar rhabdomyosarcoma with t(2;13), t(1;13), or neither transloc. by pos. or neg. RTPCR on peripheral blood and marrow spec. at diagnosis and at end of tx [ Designated as safety issue: No ]

Estimated Enrollment: 518
Study Start Date: September 2002
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven disease of any of the following types:

    • Nonmetastatic alveolar rhabdomyosarcoma

      • Stage I, II, or III; Clinical Group I, II, or III

    • Stage II or III, Clinical Group III embryonal rhabdomyosarcoma

      • Botryoid
      • Spindle cell

    • Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma

      • Botryoid
      • Spindle cell

    • Undifferentiated sarcoma

      • Stage I, II, or III; Clinical Group I, II, or III

    • Ectomesenchymoma

      • Stage I, II, or III; Clinical Group I, II, or III, with alveolar features
      • Under 10 years, Stage IV, Clinical Group IV, with embryonal features
  • No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis
  • No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases

PATIENT CHARACTERISTICS:

Age:

  • Under 50

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine normal* for age NOTE: *Patients with tumor obstruction causing creatinine elevation may be enrolled

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003958

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of South Alabama Cancer Research Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801-1428
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Lucile Packard Children's Hospital at Stanford University Medical Center
Palo Alto, California, United States, 94304
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Southern California Permanente Medical Group
Downey, California, United States, 90242
Sutter Cancer Center
Sacramento, California, United States, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8064
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176-2197
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States, 33021
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
Miami Children's Hospital
Miami, Florida, United States, 33155
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States, 33677-4227
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0296
United States, Georgia
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31405
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Rush University Medical Center
Chicago, Illinois, United States, 60612
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9658
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60601
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
St. Vincent Hospitals and Health Care Centers
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-3830
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
United States, Maine
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
Pediatric Specialty Clinic at Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-7223
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Walter Reed Army Medical Center
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007-5364
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Hurley Medical Center
Flint, Michigan, United States, 48503
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0914
Van Elslander Cancer Center at St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073-6769
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2168
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Valerie Fund Children's Center at Atlantic Health
Summit, New Jersey, United States, 07901
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Comprehensive Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Children's Hospital at Albany Medical Center
Albany, New York, United States, 12208
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8174
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
New York Medical College
Valhalla, New York, United States, 10595
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858-4354
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233
United States, North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo, North Dakota, United States, 58103-4940
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
Toledo Children's Hospital
Toledo, Ohio, United States, 43601
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
Children's Hospital at Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Doernbecher Children's Hospital at Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States, 29203
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105-1080
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37614-0622
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Center for Cancer Prevention and Care at Scott and White Clinic
Temple, Texas, United States, 76508
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States, 78229-3902
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Children's Hospital of Austin
Austin, Texas, United States, 78701
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-9063
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion Medical Center for Children at Roanoke Community Hospital
Roanoke, Virginia, United States, 24029
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
INOVA Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0212
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-5100
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Group Health Central Hospital
Seattle, Washington, United States, 98112
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-0001
Mary Bridge Children's Hospital and Health Center - Tacoma
Tacoma, Washington, United States, 98415-0299
United States, West Virginia
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25302
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-9070
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54301
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449-5772
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, New South Wales
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8S 4J9
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
New Zealand
Starship Children's Health
Auckland, New Zealand
Puerto Rico
Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
San Jorge Children's Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, CH 1011
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Carola A. S. Arndt, MD Mayo Clinic
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Arndt CA, Stoner JA, Hawkins DS, Rodeberg DA, Hayes-Jordan AA, Paidas CN, Parham DM, Teot LA, Wharam MD, Breneman JC, Donaldson SS, Anderson JR, Meyer WH. Vincristine, Actinomycin, and Cyclophosphamide Compared With Vincristine, Actinomycin, and Cyclophosphamide Alternating With Vincristine, Topotecan, and Cyclophosphamide for Intermediate-Risk Rhabdomyosarcoma: Children's Oncology Group Study D9803. J Clin Oncol. 2009 Sep 21; [Epub ahead of print]
Arndt CA, Hawkins DS, Stoner JA, et al.: Randomized phase III trial comparing vincristine, actinomycin, cyclophosphamide (VAC) with VAC/V topotecan/cyclophosphamide (TC) for intermediate risk rhabdomyosarcoma (IRRMS). D9803, COG study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9509, 528s, 2007.
Arndt C, Hawkins D, Anderson JR, Breitfeld P, Womer R, Meyer W. Age is a risk factor for chemotherapy-induced hepatopathy with vincristine, dactinomycin, and cyclophosphamide. J Clin Oncol. 2004 May 15;22(10):1894-901. Erratum in: J Clin Oncol. 2004 Aug 15;22(16):3434. Correction of dosage error in text.
Petricoin EF 3rd, Espina V, Araujo RP, Midura B, Yeung C, Wan X, Eichler GS, Johann DJ Jr, Qualman S, Tsokos M, Krishnan K, Helman LJ, Liotta LA. Phosphoprotein pathway mapping: akt/mammalian target of rapamycin activation is negatively associated with childhood rhabdomyosarcoma survival. Cancer Res. 2007 Apr 1;67(7):3431-40.

Study ID Numbers: CDR0000067157, COG-D9803, CCG-D9803, POG-D9803, IRS-D9803
Study First Received: November 1, 1999
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00003958     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
embryonal childhood rhabdomyosarcoma
alveolar childhood rhabdomyosarcoma
embryonal-botryoid childhood rhabdomyosarcoma
nonmetastatic childhood soft tissue sarcoma
childhood malignant mesenchymoma
previously untreated childhood rhabdomyosarcoma
 adult rhabdomyosarcoma
adult malignant mesenchymoma
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage I adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Anti-Bacterial Agents
Dactinomycin
Therapeutic Uses
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Rhabdomyosarcoma
 Neoplasms by Histologic Type
Myosarcoma
Mitosis Modulators
Vincristine
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Sarcoma
Antineoplastic Agents, Alkylating
Topotecan

ClinicalTrials.gov processed this record on November 25, 2009



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