Pilot Study of Hyaluronic Acid Gel Spacers for Cervical Cancer Chemoradiotherapy with Brachytherapy Evaluating Safety and Organ Protection During Radiation Treatment

What this Trial Is About

Researchers are evaluating the use of a hyaluronic acid-based gel spacer called Barrigel in women with cervical cancer who are undergoing chemoradiotherapy, including brachytherapy. The study is a Phase 1 pilot feasibility trial aiming to see if placing this gel can safely reduce radiation exposure to nearby healthy organs such as the rectum and bladder while improving radiation delivery to the tumor. This approach builds on the established use of gel spacers in prostate cancer treatment to potentially improve outcomes and reduce side effects in cervical cancer treatment. Participants will receive the Barrigel gel spacer during their standard chemoradiotherapy with brachytherapy. The gel is placed between the cervix and the rectum to increase the space and protect healthy tissue from radiation. The study focuses on assessing how feasible and safe it is to use this gel spacer, including measuring the procedure time and difficulty of placement. This intervention is integrated into the usual radiation treatment schedule, with monitoring continuing up to seven weeks during treatment. During the study, participants will be closely monitored for safety through assessments of adverse events, patient-reported bowel symptoms, and other side effects up to three months after completing radiotherapy. Imaging and measurements will evaluate the distance created by the gel between pelvic organs and the rectum. The study will also assess implant geometry at the end of radiotherapy. Overall, participants can expect regular evaluations to track safety, treatment delivery, and any effects from the gel spacer over several months.

Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies