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Radiation Therapy

Adaptive Radiation for Anal Cancer

N/A

Recruiting

Led By Lisa Kachnic, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following the completion of chemoradiation

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at using tailored radiation treatment for locally advanced anal cancer. Daily plans are used to maximize dose to the tumor and minimize dose to surrounding organs.

Who is the study for?

This trial is for adults with advanced anal squamous cell cancer, who are in good health otherwise and have not had prior treatments for this cancer. They must be able to perform daily activities without significant assistance (ECOG ≤2) and agree to use contraception during the study.

What is being tested?

The study tests a new approach using AI-guided radiation therapy tailored daily, combined with chemotherapy drugs like 5-Fluorouracil, Capecitabine, or Mitomycin-C. It aims to improve targeting of the tumor while protecting healthy tissue.

What are the potential side effects?

Possible side effects include skin reactions from radiation, fatigue, nausea from chemotherapy drugs, low blood counts increasing infection risk, and potential liver function changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following the completion of chemoradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months following the completion of chemoradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following the completion of chemoradiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to plan and deliver treatment fractions.

Secondary study objectives

Acute Treatment Toxicity

Complete Clinical Response Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemotherapy and Adaptive Radiation Treatment PlanningExperimental Treatment4 Interventions

Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~4280

5-Fluorouracil

2012

Completed Phase 3

~7800