Research and Clinical Trials

COG ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma
Brief Description  
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
Who may be Eligible  

  • 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:
      • 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:
      • 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)
  • 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
  • Under 50 years old
    • No infants who would not be able to receive study radiotherapy, in the opinion of the treating physician
  • Not pregnant or nursing
  • No uncontrolled infection
  • No prior chemotherapy (except for patients treated on the related intermediate-risk study)
  • Prior steroids allowed
  • No prior radiotherapy
IRB Number  
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Wendy  , Bissette
Phone:  (704) 355-9081  Fax:  (704) 355-1188  
Address:1025 Morehead Medical Drive