Comparing Safety and Effectiveness of ChemotherapyRadiotherapy Followed by Stereotactic Radiotherapy or Brachytherapy in Women With Cervical Cancer Stages IB3-IIIC1

What this Trial Is About

Cervical cancer is a leading cause of death among women, particularly those with locally advanced disease stages. This trial investigates whether stereotactic body radiotherapy SBRT can be as safe and effective as the standard brachytherapy boost when combined with chemotherapy and radiotherapy in treating cervical cancer stages IB3 to IIIC1. The study aims to provide new treatment options for patients, especially where brachytherapy is less accessible. Participants are randomly assigned to one of two treatment groups one receiving chemotherapy and radiotherapy followed by SBRT as a boost, and the other receiving chemotherapy and radiotherapy followed by high-dose-rate 3D intracavitary brachytherapy. Both groups receive a minimum radiation dose of 45 Gy with cisplatin, and the boost dose is delivered in 4 fractions at intervals of at least 40 hours to achieve a comparable total dose. The study focuses on comparing these two radiation boost methods. Throughout the study, participants undergo scheduled visits, imaging tests like CT or MRI scans, laboratory exams, and complete quality of life questionnaires. Researchers monitor safety using acute and chronic toxicity criteria, assess local disease control, overall and progression-free survival, and track quality of life over five years. The study includes thorough follow-up to evaluate treatment outcomes and side effects, lasting up to five years from treatment start.

Cervical Boost by Ablative Stereotactic Radiotherapy (SABR) vs Brachytherapy in Patients With Cervical Carcinoma