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RECRUITING

NCT05838391

Adaptive Radiation in Anal Cancer

Sponsor: Columbia University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-18

Completion Date

2028-12-31

Last Updated

2026-02-03

Healthy Volunteers

Conditions

Anal Squamous Cell Carcinoma

Interventions

RADIATION

Artificial 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.

DRUG

Mitomycin-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.

DRUG

5-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.

DRUG

Capecitabine

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.

Inclusion Criteria: * 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%). * Life expectancy of greater than 12 months. * Patients must have normal organ and marrow function as defined below: * leukocytes greater than or equal to 3,000/microliter * absolute neutrophil count greater than or equal to 1,500/microliter * platelets greater than or equal to 100,000/microliter * total bilirubin within normal institutional limits * Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. * Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * 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. * Prior allergic reaction to 5-Fluorouracil or mitomycin C. * Artificial organ prosthetics, pacemakers or other implantable devices. * Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields. * Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease. * Women who are pregnant or lactating.

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Clinical Research Directory

Adaptive Radiation in Anal Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)