Study Comparing Different Chemotherapy Approaches for Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma

Program Overview

The study aims to find out which chemotherapy approach is better for treating intermediate-risk rhabdomyosarcoma: a higher dose given over a shorter time or a lower dose with maintenance therapy over a longer time. Both approaches include standard surgery and radiation. The trial will help determine which method improves survival and reduces cancer recurrence.

Description

This study is testing two different chemotherapy plans for patients with newly diagnosed intermediate-risk rhabdomyosarcoma, a cancer that affects soft tissues.

Plan A:

• Patients receive higher doses of chemotherapy drugs (vincristine, dactinomycin, and cyclophosphamide) over a shorter period.
• Treatment cycles repeat every 21 days unless the cancer progresses or side effects become too severe.
• Surgery and radiation may be part of the treatment during specific cycles.

Plan B:

• Patients receive lower doses of chemotherapy drugs (vincristine, dactinomycin, cyclophosphamide, and irinotecan) with additional maintenance therapy (vinorelbine and cyclophosphamide) over a longer period.
• Treatment cycles repeat every 21 days, with maintenance cycles every 28 days for 6 cycles.
• Surgery and radiation may be part of the treatment during specific cycles.

The study will compare the effectiveness of these plans in terms of survival rates, side effects, and cancer recurrence. Patients will undergo regular scans and tests to monitor their progress. After completing the treatment, patients will have follow-up visits every few months for up to five years.

Eligibility Criteria

Locations