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Sarcoma

Combination Chemotherapy + Radiation for Newly Diagnosed Rhabdomyosarcoma (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)
Status Conditions Phase Study ID
Recruiting Sarcoma; Solid Tumors Phase III COG ARST0531
NCT00354835
Summary

RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.

PURPOSE: 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.


Investigator
Doug Hawkins, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed rhabdomyosarcoma (RMS)

    • Must be concurrently enrolled on COG-D9902 to confirm local histologic diagnosis
  • 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
  • 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
Last Updated
June 02, 2010
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.