Phase II Study Comparing Hypofractionated and Conventional Radiotherapy with Cisplatin and Brachytherapy for Advanced Cervical Cancer in Uganda

What this Trial Is About

Researchers are evaluating hypofractionated radiotherapy HFRT compared to conventional fractionated radiotherapy CFRT in women with locally advanced cervical cancer stages IB3, II, or III. This phase II trial aims to determine if HFRT, which delivers higher radiation doses over a shorter time, is as safe and effective as CFRT when combined with cisplatin chemotherapy and brachytherapy. The study also investigates toxicity, tumor control, survival rates, treatment costs, and quality of life in patients treated in Uganda. Participants are randomly assigned to one of two groups. The HFRT group receives 40 Gy of radiation in 16 fractions over about 3 weeks, with concurrent weekly cisplatin infusions and optional high-dose rate brachytherapy starting in week 4. The CFRT group receives 45 Gy in 25 fractions over about 5 weeks, with the same concurrent treatments and options. Patients who cannot have brachytherapy receive an external beam radiotherapy boost. Throughout treatment, patients undergo CT scans and blood sample collections. After treatment, participants are followed for up to two years with check-ups at 1, 3, 6, 12, 18, and 24 months. Researchers monitor side effects, especially gastrointestinal and urinary toxicities, and assess tumor response and survival. They also collect blood samples to study cancer markers and evaluate patient-reported outcomes and costs. The total participation period includes treatment and follow-up visits to fully assess safety and effectiveness.

Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda