Clinical Trial: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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 more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.


Detailed Summary:

OBJECTIVES:

  • Determine the progression-free survival rate in patients with low-risk embryonal rhadomyosarcoma treated with a shortened treatment schedule of vincristine, dactinomycin, and cyclophosphamide with or without radiotherapy.

OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.


Sponsor: Japan Rhabdomyosarcoma Study Group

Current Primary Outcome: Disease-free survival as measured by Kaplan-Meier method 3 years after study entry

Original Primary Outcome:

Current Secondary Outcome:

  • Overall survival as measured by Kaplan-Meier method 3 years after study entry
  • Progression-free survival as measured by Kaplan-Meier method during events
  • Complete response rate (orbit, group III only) at completion of study treatment
  • Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 25, 2005
Date Started: May 2004
Date Completion:
Last Updated: August 9, 2013
Last Verified: July 2009