A Phase II Study Comparing Proton Therapy and Photon Therapy for Pelvic Nodal Radiation in Newly Diagnosed Gynecologic Cancers

What this Trial Is About

Researchers are comparing side effects between two types of radiation therapy for women with newly diagnosed endometrial or cervical cancer. The study evaluates Conventional Photon radiation versus Proton radiation to understand differences in treatment-related gastrointestinal toxicity and other effects. This is a Phase II randomized trial conducted to improve care for these gynecologic cancers. Participants will be randomly assigned to receive either Photon Radiation Therapy using Volume Modulated Arc Therapy VMAT or Proton Radiation Therapy using Intensity Modulated Proton Therapy IMPT. Both groups receive radiation doses of 45-50.4 Gy given in 1.8-2 Gy fractions. Concurrent weekly cisplatin chemotherapy is also given during external beam radiation, but not during HDR brachytherapy. Treatments follow current standards of care. During the study, participants are monitored for acute and late side effects, including gastrointestinal, genitourinary, and blood-related toxicities, for up to two years after treatment. Assessments include clinical evaluations and toxicity grading using CTCAE criteria. Researchers also track treatment completion rates and survival outcomes. The total study period extends through follow-up to capture these important measures.

GCCC 2578 Randomized Photon vs Proton RT for Newly Diagnosed Gynecologic Primaries