PROTECT Phase II Study Comparing Proton and Standard Radiation Therapy with Chemotherapy for Women with Locally Advanced Cervical Cancer

What this Trial Is About

Researchers are evaluating the differences between intensity modulated proton therapy IMPT and standard radiation therapies IMRT or VMAT in women with locally advanced cervical cancer undergoing chemoradiation. This phase-II, prospective, multicenter trial aims to compare the effects on radiation dose to organs and treatment-related side effects, including impacts on the immune system and quality of life. Thirty women aged 18 and older with a confirmed diagnosis of locally advanced cervical cancer will participate in this study. Participants will receive external beam radiation therapy EBRT totaling 45 Gy delivered in 25 daily fractions over 5 weeks, combined with weekly cisplatin chemotherapy for five weeks. After EBRT, all patients undergo MRI-guided adaptive brachytherapy with a high-dose rate system delivering 21 to 28 Gy in fractions of 7 Gy. Women are assigned to either the IMPT group or the IMRTVMAT group, both receiving chemotherapy and brachytherapy as standard care. The study monitors the dose to pelvic bones and bowel as primary measures. During the study, participants will have multiple assessments including imaging, blood tests, and questionnaires to monitor radiation doses to various organs, immune system effects, treatment safety, tolerability, and quality of life at baseline, during treatment, and up to 12 months after treatment ends. Researchers will also evaluate cancer control by checking survival and recurrence at 3 and 12 months. Follow-up visits include evaluations of immune response and bone marrow changes. The total participation includes treatment and up to one year of follow-up.

PROTECT: On-line Adaptive Proton Therapy for Cervical Cancer