RecruitingNot ApplicableNCT05838391

Adaptive Radiation in Anal Cancer

Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma

Sponsor

Columbia University

Enrollment

20 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Anal Squamous Cell Carcinoma

Summary

This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing adaptive radiation therapy — a more personalized type of radiation that adjusts to changes in tumor size during treatment — for people with anal canal cancer. The goal is to see if this approach reduces side effects while remaining effective. **You may be eligible if...** - You have been diagnosed with anal canal cancer confirmed by biopsy - Your tumor is T2 (larger than 4 cm), T3, T4, or involves nearby lymph nodes - You are 18 or older and in reasonably good health - Your blood counts and organ function are within acceptable ranges - Your life expectancy is greater than 12 months **You may NOT be eligible if...** - You have previously had pelvic radiation therapy - You are pregnant - You have a serious active infection or uncontrolled medical condition - You cannot complete the required imaging or treatment visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONArtificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery

Subjects will receive 54 Gy of radiation delivered 5 day a week for 6 weeks, 30 radiation treatments total. Intensity-Modulated photon radiation therapy will be delivered on a Varian Ethos linear accelerator. Daily image-guided radiation therapy (IGRT) is required. All treatments will have artificial-intelligence (AI) daily adaptations of the radiation plan to optimize the radiation dose to the targeted area and minimize radiation dose to the normal surrounding organs such as the bowel.

DRUGMitomycin-C

As part of the subjects' treatment, 10 mg/meters squared of Mitomycin C will be administered intravenously (IV-into the vein) on Day 1 and Day 29.

DRUG5-Fluorouracil

As part of the subjects' treatment, 1g/meters squared/day for 4 days of 5-Fluorouracil will be administered by continuous infusion on Days 1-4 (for 96 hours) and Days 29-32 (for 96 hours). 5-Fluorouracil or capecitabine will be administered per the physician's discretion.

DRUGCapecitabine

As part of the subjects' treatment, 825 mg/meters squared per day, divided into 2 daily doses, will be taken on days of radiotherapy. Capecitabine or 5-FU will be administered per the physician's discretion.