Clinical Trial: Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma

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

Official Title: Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma

Brief Summary: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

Detailed Summary:

OBJECTIVES:

I. Compare the early response rates, failure-free survival, and survival of patients with intermediate-risk rhabdomyosarcoma treated with surgery, radiotherapy, and vincristine, dactinomycin, and cyclophosphamide (VAC) vs VAC alternating with vincristine, topotecan, and cyclophosphamide.

II. Compare the acute and late effects of these two treatment regimens in these patients.

III. Determine the rate of second-look surgery in selected patients with bulk residual tumor at diagnosis (i.e., Clinical Group III) and the proportion of these that render the patient tumor free or with microscopic tumor only.

IV. Determine the rate of local failure in selected patients with bulk residual tumors at diagnosis (i.e., Clinical Group III) who, after second-look resection, have response-adjusted radiotherapy dose reduction.

V. Determine if preoperative radiotherapy followed by second-look surgery is feasible for selected patients with bulk residual disease (i.e., Clinical Group III) who respond poorly to induction chemotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease (embryonal histology, stage II or III, Clinical Group III vs embryonal histology, Clinical Group IV, less than 10 years of age vs alveolar or undifferentiated sarcoma histology, stage I, Clinical Group I vs alveolar or undifferentiated sarcoma histology, stage II or III, Clinical Group II or III). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive vincristine IV over 5-10 minutes once a week on weeks 0-12, 15, 18-24, 27, 30-36, and 39. Dactin
Sponsor: Children's Oncology Group

Current Primary Outcome: Long-term failure-free survival (FFS) between the two treatment groups [ Time Frame: Up to 5 years ]

Original Primary Outcome:

Current Secondary Outcome:

  • Overall survival between treatments [ Time Frame: Up to 5 years ]
  • Rate of second look surgery [ Time Frame: Week 12 ]
  • Proportion of patients rendered tumor-free or with microscopic tumor only [ Time Frame: Week 12 ]
  • Estimation of the rate of local failure for the patients who undergo second look surgery [ Time Frame: Week 12 ]
    Done using standard cumulative incidence curves.


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: November 1, 1999
Date Started: September 2002
Date Completion:
Last Updated: June 13, 2013
Last Verified: June 2013