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

Completed · Phase 3

Conditions studied: Adult Rhabdomyosarcoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Previously Untreated Childhood Rhabdomyosarcoma

In brief

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.

Key facts

Study ID

NCT00075582

Run by

Children's Oncology Group

People needed

390

Starts

2004-09-04

Expected to finish

2021-09-30

Last updated by the study team

2021-11-19

Who can join

Age: any, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• 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)*

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's Oncology Group — Arcadia, California, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Memorial Healthcare System - Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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