Clinical Trial: Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdo

Brief Summary: This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine (V), dactinomycin (A), cyclophosphamide (C), and radiotherapy.

SECONDARY OBJECTIVES:

I. Determine local control rates in patients treated with this regimen. II. Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with microscopic tumor only and evaluate the pathologic significance of that residual tumor.

III. Determine the local control rates in patients with clinical group III disease treated with response-adjusted radiotherapy doses after second-look surgical resection.

OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.

REGIMEN I (subset 1 patients) [closed to accrual as of 08/13/2010: Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin* IV over 1 minute on day 1 of weeks 13, 16, 19, and 22; and radiotherapy**, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose.

REGIMEN II (subset 2 patients)[closed to accrual as of 9/23/2011]: Patients receive VAC chemotherapy and radiotherapy** as in regi
Sponsor: Children's Oncology Group

Current Primary Outcome:

• Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval) [ Time Frame: 5 years from study enrollment ]
  Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.
• Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years [ Time Frame: 5 years from study enrollment ]
  Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.
• Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval). [ Time Frame: 5 years from study enrollment ]
  Failure free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.

Original Primary Outcome:

Current Secondary Outcome:

• Rate of Local Failure for Patients Who Receive Reduced Doses of Radiation Therapy [ Time Frame: Up to 10 years ]
  The local failure rate will be estimated using cumulative incidence curves.
• Rate of Second-look Surgery and the Proportion of Patients Who Are Tumor-free or With Microscopic Tumor Only Following Second-look Surgeries [ Time Frame: At 13 weeks ]
  The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.
• Rate of Local Failure for Patients With Clinical Group III Disease When the Radiotherapy Dose is Reduced After Second-look Surgical Resection. [ Time Frame: Up to 20 weeks ]
  The local failure rate will be estimated using cumulative incidence curves.

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: January 9, 2004
Date Started: September 2004
Date Completion:
Last Updated: November 2, 2016
Last Verified: October 2016