Research and Clinical Trials

COG ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS) (COG and NCI)
Brief Description  
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma
Who may be Eligible  

  • Histologically or cytologically confirmed rhabdomyosarcoma (RMS)
  • Intermediate-risk disease, defined by 1 of the following surgicopathologic and staging criteria:
    • Group III, stage 2 or 3 embryonal, botryoid, or spindle cell RMS
    • Group III, stage 2 or 3 ectomesenchymoma
    • Group I-III, stage 1-3 alveolar RMS
  • Newly diagnosed disease
  • Up to 50 years old
  • Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) required for patients = 10 years of age with paratesticular tumors and for patients < 10 years with clinically or radiographically involved lymph nodes
    • Patients with extensive lymph node involvement, defined as = 2 lymph nodes > 2 cm in dimension, identified by imaging studies, are not required to undergo SIRLND
  • Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors
  • Has undergone initial surgery or biopsy within the past 42 days
  • Must be able to undergo radiotherapy

  • Not pregnant or nursing
  • No evidence of uncontrolled infection

  • No prior chemotherapy* (excluding steroids)
  • No prior radiotherapy*
  • No concurrent aprepitant during treatment with cyclophosphamide
IRB Number  
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Lynnae   , Schwandt
Phone:  (704) 355-1188  Fax:  (704) 446-1989  
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204