Study of AI-Guided Adaptive Radiation and Chemotherapy for Locally Advanced Anal Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the feasibility of using dose-adapted radiation therapy guided by artificial intelligence for treating locally advanced anal squamous cell carcinoma. This pilot study involves 20 patients and aims to determine if daily adjustments to radiation plans based on changes in tumor size and patient anatomy can improve treatment precision. The study focuses on tumors larger than 4 cm or with positive lymph nodes, combining radiation with chemotherapy as standard care. Participants will receive 54 Gy of radiation delivered five days a week over six weeks, using intensity-modulated photon radiation therapy on a Varian Ethos linear accelerator. The radiation plan will be adapted daily using AI to optimize the dose to the tumor while minimizing exposure to nearby organs. Concurrent chemotherapy includes mitomycin C administered intravenously on Days 1 and 29, and either 5-Fluorouracil given by continuous infusion on Days 1-4 and 29-32 or oral capecitabine on radiation days, chosen by the physician. During the study, patients will undergo weekly imaging with Cone Beam CT to monitor tumor size and anatomy changes. Researchers will measure the time needed to plan and deliver each radiation treatment over six weeks, evaluate acute treatment side effects for up to one month after therapy, and assess clinical response six months after completion. Patients will be closely monitored throughout treatment, and participation is expected to last at least six months with scheduled assessments and follow-up.

Adaptive Radiation in Anal Cancer