Prospective Randomized Validation of Adaptive Radiotherapy in Patients With Gynecological Tumors and Indication for Radiotherapy

What this Trial Is About

Researchers are evaluating adaptive radiotherapy (ART) in patients with locally advanced gynecological cancers such as cervical, endometrial, and vaginal carcinomas. This study compares ART, a newer method that adjusts radiation doses based on daily anatomical changes, with standard image-guided radiotherapy (IGRT) where the radiation plan remains fixed. The goal is to understand how many patients benefit from ART and whether it can reduce radiation exposure to healthy tissues and safety margins. Participants receive either ART or standard IGRT during their radiotherapy treatment. ART involves online adaptation of the radiation dose distribution before each session using cone-beam CT scans and expert review by a radiation oncologist and medical physicist. Treatments are delivered over an initial 10 radiation fractions using the Ethos therapy device. If ART does not provide dosimetric advantages, the original treatment plan is used as in IGRT. The study includes an experimental adaptive radiotherapy arm and a standard IGRT comparator arm. During the study, participants will be monitored for side effects using established toxicity scales for rectal, bladder, skin toxicities, and lymph-edema from 2 weeks up to 5 years. Overall survival and progression-free survival will be assessed over 5 years. Researchers will compare dose distributions and analyze safety margins. The study is randomized and double-blinded, with involvement lasting through treatment and long-term follow-up for outcomes and safety.

Adaptive Radiotherapy in Patients With Gynecological Tumors