Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
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): 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, administered as
in regimen I, and continued VA* chemotherapy as in regimen I or II. 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Failure-free survival (FFS) for patients with low-risk rhabdomyosarcoma in subset 1
An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients. The monitoring boundary p-values associated with the 3 interim looks using the O'Brien-Fleming spending function truncated at 3.00 will be 0.001, 0.020, and 0.052, with the final analysis being done with p=0.082. The type I error associated with this monitoring plan is about 0.10.
Up to 10 years
No
David Walterhouse
Principal Investigator
Children's Oncology Group
United States: Institutional Review Board
ARST0331
NCT00075582
September 2004
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
Hurley Medical Center | Flint, Michigan 48503 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Eastern Maine Medical Center | Bangor, Maine 04401 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Advocate Hope Children's Hospital | Oak Lawn, Illinois 60453 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Scott and White Memorial Hospital | Temple, Texas 76508 |
Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Mount Sinai Medical Center | New York, New York 10029 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Rady Children's Hospital - San Diego | San Diego, California 92123-4282 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Research Center at Oakland | Oakland, California 94609-1809 |
Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania 18017 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
University of Virginia | Charlottesville, Virginia 22908 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
University of Rochester | Rochester, New York 14642 |
Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
Helen DeVos Children's Hospital at Spectrum Health | Grand Rapids, Michigan 49503 |
Wayne State University | Detroit, Michigan 48202 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University Of Vermont | Burlington,, Vermont 05403 |
Albany Medical Center | Albany, New York 12208 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
UC Davis Comprehensive Cancer Center | Sacramento, California 95817 |
Oregon Health and Science University | Portland, Oregon 97201 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Virginia Commonwealth University | Richmond, Virginia |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
Childrens Memorial Hospital | Chicago, Illinois 60614 |
Kaiser Permanente-Oakland | Oakland, California 94611 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Luke's Mountain States Tumor Institute | Boise, Idaho 83712 |
Michigan State University - Breslin Cancer Center | East Lansing, Michigan 48824-1313 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Columbia University Medical Center | New York, New York 10032 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
Mission Hospitals Inc | Asheville, North Carolina 28801 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
University of Illinois | Chicago, Illinois 60612 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
Memorial Healthcare System - Joe DiMaggio Children's Hospital | Hollywood, Florida 33021 |
West Virginia University Charleston | Charleston, West Virginia 25304 |
The Children's Medical Center of Dayton | Dayton, Ohio 45404 |
Advocate Lutheran General Hospital | Park Ridge, Illinois 60068 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
University of Minnesota Medical Center-Fairview | Minneapolis, Minnesota 55455 |
Children's Oncology Group | Arcadia, California 91006-3776 |
C S Mott Children's Hospital | Ann Arbor, Michigan 48109 |
Southern Illinois University | Springfield, Illinois 62702 |
Cardinal Glennon Children's Medical Center | St. Louis, Missouri 63104 |
UMDNJ - Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Phoenix Childrens Hospital | Phoenix, Arizona 85016 |
Miller Children's Hospital | Long Beach, California 90806 |
Childrens Hospital of Orange County | Orange, California 92868-3874 |
Nemours Children's Clinic - Jacksonville | Jacksonville, Florida 32207-8426 |
Saint Joseph Children's Hospital of Tampa | Tampa, Florida 33607 |
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia 30322 |
The Childrens Mercy Hospital | Kansas City, Missouri 64108 |
Rainbow Babies and Childrens Hospital | Cleveland, Ohio 44106 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |
East Tennessee Childrens Hospital | Knoxville, Tennessee 37916 |
Saint Mary's Hospital | West Palm Beach, Florida 33407 |
Children's Hospital and Medical Center of Omaha | Omaha, Nebraska 68114 |
Childrens Hospital-King's Daughters | Norfolk, Virginia 23507 |
Children's Hospital Colorado | Aurora, Colorado 80045 |
Lucile Packard Children's Hospital Stanford University | Palo Alto, California 94304 |
University of California San Francisco Medical Center-Parnassus | San Francisco, California 94143 |
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver, Colorado 80218 |
Raymond Blank Children's Hospital | Des Moines, Iowa 50309 |
Children's Hospital-Main Campus | New Orleans, Louisiana 70118 |
Saint Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134 |
Greenville Cancer Treatment Center | Greenville, South Carolina 29605 |
T C Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington 99204 |
Broward Health Medical Center | Fort Lauderdale, Florida 33316 |
The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York 11040 |