Recruiting

Adaptive Radiotherapy for Locally-Advanced Anal Squamous Cell Carcinoma Treatment

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Study Aim

This study aims to measure the time it takes to plan and deliver treatment fractions using adaptive radiotherapy for locally-advanced anal squamous cell carcinoma.

What is being tested

Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery

+ Mitomycin-C

+ 5-Fluorouracil

RadiationDrug
Who is being recruted

Anus Diseases+10

+ Anus Neoplasms

+ Digestive System Diseases

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorColumbia University
Study ContactChristina Chesnakov
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 18, 2023

Actual date on which the first participant was enrolled.

This study focuses on a specific type of cancer, known as HPV-positive locally advanced anal cancer. This is a condition where the tumor is larger than 4 cm, or has spread to the lymph nodes. The standard treatment for this cancer involves radiation therapy and chemotherapy, specifically 5-fluorouracil (5-FU) and mitomycin-C. The radiation therapy is usually given over six weeks. During this time, the tumor often shrinks, which can be seen on weekly scans. However, the treatment plan is typically not adjusted to account for this shrinkage due to various constraints. This study aims to explore a more efficient method, called daily adaptive radiation, which could adjust the treatment plan based on the tumor's current size, potentially improving the treatment process. During the study, participants will receive their usual treatment, but with a key difference. The radiation therapy will be adapted daily based on the tumor's size, using a technique called adaptive radiotherapy. The main goal is to measure how long it takes to plan and deliver each treatment fraction, from the start of the first scan to the end of treatment delivery. This will help determine if daily adaptive radiation is a practical and efficient approach for treating this type of cancer.

Official TitleFeasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
NCT05838391
Principal SponsorColumbia University
Study ContactChristina Chesnakov
Last updated: February 4, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Anus DiseasesAnus NeoplasmsDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by SiteRectal DiseasesRectal NeoplasmsColorectal Neoplasms

Criteria

14 inclusion criteria required to participate
Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.

American Joint Committee on Cancer (AJCC) 8th edition stage T2 > 4 cm, T3-4 or N1.

Age ≥18 years.

Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).

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9 exclusion criteria prevent from participating
Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.

Prior chemotherapy or radiation for anal cancer.

Patients who have undergone complete surgical resection.

Presence of recurrent/metastatic disease.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Columbia University Irving Medical Center

New York, United StatesOpen Columbia University Irving Medical Center in Google Maps
Recruiting
One Study Center