Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

• Status: Active, not recruiting
• Trial end date: 2030-06-01

Summary

This study will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic chemotherapy.

PRIMARY OBJECTIVE:

• Estimate event-free survival for intermediate risk participants treated with vincristine, dactinomycin and cyclophosphamide with the addition of maintenance anti-angiogenic therapy.

SECONDARY OBJECTIVES:

• Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection.

• Maintain a high local control rate in participants treated with surgery and/or limited volume proton and photon radiation without dose escalation.

• Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume.

• Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic chemotherapy in intermediate and high risk patients following standard chemotherapy.

• Estimate the event free survival for high risk patients receiving interval dose compressed therapy and maintenance anti-angiogenic therapy.

• Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.

• Phase: Phase 2

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: Bevacizumab; Cyclophosphamide; Dactinomycin; Dexrazoxane; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Irinotecan; Isophosphamide mustard; Lenograstim; Liposomal doxorubicin; Mitogens; Razoxane; Sorafenib; Vincristine