Clinical Trial: Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol

Brief Summary:

RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

Detailed Summary:

OBJECTIVES:

• Determine the failure-free survival (FFS) rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy.
• Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy.
• Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments.
• Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens.

OUTLINE: Patients are assigned to 1 of 2 groups, depending on histology and site of disease.

• Group I (favorable tumor site, negative lymph nodes, stage 1, clinical group I, IIA, or III (orbit only), node negative [N0] OR unfavorable tumor site, negative or unknown lymph nodes, stage 2, clinical group I): Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every 12 weeks for 4 courses. Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8.
• Group II (favorable tumor site, positive lymph nodes, stage 1, clinical group III (orbit only), node positive [N1] OR favorable tumor site except orbit, any lymph nodes, stage 1, clinical group III OR unfavorable tumor site, stage 2, clinical g
  Sponsor: Children's Oncology Group
  

  Current Primary Outcome: Failure-free survival
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Children's Oncology Group
  

  Dates:
  Date Received: November 1, 1999
  Date Started: August 1997
  Date Completion:
  Last Updated: February 12, 2014
  Last Verified: February 2014