Adult RhabdomyosarcomaPhase 3NCT00075582
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
A Phase 3 study testing conventional surgery, dactinomycin and cyclophosphamide in people with Adult Rhabdomyosarcoma and Embryonal Childhood Rhabdomyosarcoma, run by Children's Oncology Group at 163 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 49 years
- Conditions the study is for
- Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma
- What is being tested?
- conventional surgery, dactinomycin and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 163 sitesin 6 countries
- Study dates
- 4 Sep 2004to 30 Sep 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
- Subset 1, defined by meeting 1 of the following criteria (closed to accrual as of 08/13/2010):
- Stage 1 and clinical group I (completely resected) or II (microscopic residual disease and/or regional lymph node involvement) disease
- Stage 1 and clinical group III (gross residual disease) disease arising in the orbit
- Stage 2 and clinical group I or II disease
- Subset 2, defined by meeting 1 of the following criteria (closed to accrual as of 09/23/2011):
Show all 40Show fewer
- Stage 1 and clinical group III disease arising in a non-orbit site
- Stage 3 and clinical group I or II disease
- Prior staging ipsilateral retroperitoneal lymph node dissection required for all patients age 10 and over with paratesticular tumors and patients under 10 years of age with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement is identified by imaging studies)
- If there is extensive gross node involvement only confirmatory node biopsy is recommended and the patient is classified as Clinical Group III
- Prior regional lymph node sampling required for patients with extremity tumors
- None of the following diagnoses:
- Intermediate-risk embryonal RMS
- Metastatic embryonal RMS
- Alveolar RMS
- Undifferentiated sarcoma
- RMS not otherwise specified (NOS)
- Other soft tissue sarcoma, including sarcoma NOS
- Prior enrollment on clinical trial COG-D9902
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100% (≥ 16 years old)
- Performance status - Lansky 50-100% (< 16 years old)
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75,000/mm^3 (transfusion independent)
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
- Creatinine* based on age/gender as follows:
- No greater than 0.8 mg/dL for patients age 5 and under
- No greater than 1.0 mg/dL for patients age 6 to 9
- No greater than 1.2 mg/dL for patients age 10 to 12
- No greater than 1.4 mg/dL for female patients age 13 and over
- No greater than 1.5 mg/dL for male patients age 13 to 15
- No greater than 1.7 mg/dL for male patients age 16 and over
- Creatinine clearance* or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No prior chemotherapy (except for patients treated on the related intermediate-risk study)
- Prior steroids allowed
- No prior radiotherapy
Who cannot join
None listed.
Trial locations and contacts
163 sites in 6 countries.
163 sites in 6 countries
United States138 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Albany Medical Center
Albany, New York, 12208
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Oncology Group
Arcadia, California, 91006-3776
Mission Hospitals Inc
Asheville, North Carolina, 28801
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201-1595
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Johns Hopkins University
Baltimore, Maryland, 21287-8936
Eastern Maine Medical Center
Bangor, Maine, 04401
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Brooklyn Hospital Center
Brooklyn, New York, 11201
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Vermont
Burlington, Vermont, 05401
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
West Virginia University Charleston
Charleston, West Virginia, 25304
Presbyterian Hospital
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22908
T C Thompson Children's Hospital
Chattanooga, Tennessee, 37403
University of Illinois
Chicago, Illinois, 60612
Childrens Memorial Hospital
Chicago, Illinois, 60614
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Medical City Dallas Hospital
Dallas, Texas, 75230
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, Colorado, 80218
Raymond Blank Children's Hospital
Des Moines, Iowa, 50309
Wayne State University
Detroit, Michigan, 48202
Southern California Permanente Medical Group
Downey, California, 90242
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Hurley Medical Center
Flint, Michigan, 48502
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
Cook Children's Medical Center
Fort Worth, Texas, 76104
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
Saint Vincent Hospital
Green Bay, Wisconsin, 54301
Greenville Cancer Treatment Center
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
University of Hawaii
Honolulu, Hawaii, 96813
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Baylor College of Medicine
Houston, Texas, 77030
M D Anderson Cancer Center
Houston, Texas, 77030
Indiana University Medical Center
Indianapolis, Indiana, 46202
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 32207-8426
The Childrens Mercy Hospital
Kansas City, Missouri, 64108
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Michigan State University - Breslin Cancer Center
Lansing, Michigan, 48910
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Loma Linda University Medical Center
Loma Linda, California, 92354
Miller Children's Hospital
Long Beach, California, 90806
Children's Hospital Los Angeles
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Kosair Children's Hospital
Louisville, Kentucky, 40202
Covenant Children's Hospital
Lubbock, Texas, 79410
Children's Hospital Central California
Madera, California, 93636-8762
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
Miami Children's Hospital
Miami, Florida, 33155
Baptist Hospital of Miami
Miami, Florida, 33176
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
UMDNJ - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Children's Hospital-Main Campus
New Orleans, Louisiana, 70118
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Childrens Hospital-King's Daughters
Norfolk, Virginia, 23507
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809
Kaiser Permanente-Oakland
Oakland, California, 94611
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Childrens Hospital of Orange County
Orange, California, 92868-3874
M D Anderson Cancer Center- Orlando
Orlando, Florida, 32806
Lucile Packard Children's Hospital Stanford University
Palo Alto, California, 94304
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Saint Jude Midwest Affiliate
Peoria, Illinois, 61602
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
Oregon Health and Science University
Portland, Oregon, 97239
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Primary Children's Medical Center
Salt Lake City, Utah, 84113
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
Rady Children's Hospital - San Diego
San Diego, California, 92123
University of California San Francisco Medical Center-Parnassus
San Francisco, California, 94143
Memorial Health University Medical Center
Savannah, Georgia, 31403
Maine Children's Cancer Program
Scarborough, Maine, 04074
Seattle Children's Hospital
Seattle, Washington, 98105
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Southern Illinois University
Springfield, Illinois, 62702
Baystate Medical Center
Springfield, Massachusetts, 01199
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
Washington University School of Medicine
St Louis, Missouri, 63110
All Children's Hospital
St. Petersburg, Florida, 33701
State University of New York Upstate Medical University
Syracuse, New York, 13210
Saint Joseph Children's Hospital of Tampa
Tampa, Florida, 33607
Scott and White Memorial Hospital
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10467-2490
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
New York Medical College
Valhalla, New York, 10595
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Saint Mary's Hospital
West Palm Beach, Florida, 33407
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Canada13 sites
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8S 4L8
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, H3H 1P3
Hospital Sainte-Justine
Montreal, Quebec, H3T 1C5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Janeway Child Health Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, G1V 4G2
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Australia7 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Women's and Children's Hospital-Adelaide
North Adelaide, South Australia, 5006
Royal Children's Hospital
Parkville, Victoria, 3052
Princess Margaret Hospital for Children
Perth, Western Australia, 6008
Sydney Children's Hospital
Randwick, New South Wales, 2031
The Children's Hospital at Westmead
Sydney, New South Wales, 2145
Sydney West Area Health Service-Westmead Hospital
Westmead, New South Wales, 2145
New Zealand2 sites
Christchurch Hospital
Christchurch, 8011
Starship Children's Hospital
Grafton, Auckland, 1145
Switzerland2 sites
Swiss Pediatric Oncology Group - Geneva
Geneva, 1205
Swiss Pediatric Oncology Group - Lausanne
Lausanne, 1011
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma
- Being tested
- conventional surgery, dactinomycin, cyclophosphamide, vincristine sulfate, radiation therapy
- Medical subject headings
- Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
Also called surgery, conventional
Some patients may undergo second-look surgery
dactinomycinDrug
Also called ACT-D, actinomycin C1, AD, Cosmegen
Given IV
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
Also called leurocristine sulfate, VCR, Vincasar PFS
Given IV
radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Regimen I (chemotherapy, radiotherapy) | Experimental | Patients receive VAC chemotherapy comprising vincristine sulfate 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 sulfate 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 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) Receives: Drug: dactinomycin; Drug: cyclophosphamide; Drug: vincristine sulfate; Radiation: radiation therapy |
| Regimen II (chemotherapy, radiotherapy, surgery) | Experimental | Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate 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 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). Receives: Procedure: conventional surgery; Drug: dactinomycin; Drug: cyclophosphamide; Drug: vincristine sulfate; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 1 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Measured: From enrollment up to 5 years
Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Measured: From enrollment up to 5 years
Percentage of Patients With Low-risk Rhabdomyosarcoma in Subset 2 Failure Free at 5 Years Following Study Entry
Kaplan Meier estimate of failure free survival at 5 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Measured: From enrollment up to 5 years
Secondary outcomes (3)
Cumulative Incidence of Patients Who Receive Reduced Doses of Radiation Therapy
The local failure rate will be estimated using cumulative incidence curves.
Measured: From enrollment up to 5 years
Percentage of Patients With Delayed Surgical Procedures
The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
Measured: At 13 weeks after induction
Cumulative Incidence of Group III Patients Who Received With Reduced Radiotherapy Dose
The local failure rate will be estimated using cumulative incidence curves for Group III patients who received reduced doses of radiation therapy after second look surgical resection.
Measured: From enrollment up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2004 (estimated)
- Study start4 Sep 2004
- Primary completion13 Aug 2012
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adult RhabdomyosarcomaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Walterhouse, MD, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075582
- Sponsor's protocol ID
- ARST0331
- Other IDs
- NCI-2009-00425, COG-ARST0331, CDR0000347078, U10CA098543
- Status last verified
- Nov 2021
- First submitted
- 9 Jan 2004
- Last updated
- 19 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Woolson RF (1981) Rank-tests and a one-sample log-rank test for comparing observed survival-data to a standard population. Biometrics 37: 687-696.
de Traux de Wardin H, Dermawan JK, Vanoli F, Jiang SC, Singer S, Chi P, Tap W, Wexler LH, Antonescu CR. NF1-Driven Rhabdomyosarcoma Phenotypes: A Comparative Clinical and Molecular Study of NF1-Mutant Rhabdomyosarcoma and NF1-Associated Malignant Triton Tumor. JCO Precis Oncol. 2024 Apr;8:e2300597. doi: 10.1200/PO.23.00597.
PubMed 38603649Proia AD. Spindle Cell/Sclerosing Rhabdomyosarcoma of the Orbit. Ophthalmic Plast Reconstr Surg. 2023 Jan-Feb 01;39(1):e17-e20. doi: 10.1097/IOP.0000000000002252. Epub 2022 Jul 13.
PubMed 35829629