Actively Recruiting
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
Led by Columbia University · Updated on 2026-02-03
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Adaptive Radiation in Anal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 (Karnofsky score 60% or higher).
- Life expectancy greater than 12 months.
- Normal organ and marrow function, including leukocytes ≥ 3,000/microliter, neutrophils ≥ 1,500/microliter, platelets ≥ 100,000/microliter, normal bilirubin, AST/ALT ≤ 2.5 times upper limit of normal, and normal creatinine or creatinine clearance ≥ 60 mL/min/1.73 m2.
- Agrees to use effective contraception if of childbearing potential during and for 6 months after study therapy.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Prior or co-existing invasive malignancy except non-melanomatous skin cancer unless disease free for 2 or more years.
- Previous chemotherapy or radiation therapy for anal cancer.
- Complete surgical removal of anal cancer before the study.
- Presence of recurrent or metastatic anal cancer.
- Prior allergic reaction to 5-Fluorouracil or mitomycin C.
- Presence of artificial organ prosthetics, pacemakers, or other implantable devices.
- Prior pelvic radiation overlapping treatment fields.
- Uncontrolled illnesses such as HIV with CD4 count less than 200 or symptomatic heart disease.
- Pregnant or breastfeeding women.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive concurrent chemotherapy and adaptive radiation therapy. Radiation is delivered 5 days a week for 6 weeks with daily AI-guided plan adaptations. Chemotherapy includes mitomycin C on Day 1 and Day 29, and 5-Fluorouracil or capecitabine given during radiotherapy days.
Daily visits for radiation treatment 5 days per week
Duration - Up to 6 months
Participants are monitored for acute treatment toxicity and clinical response after completing chemoradiation.
Visits up to 1 month post-treatment for toxicity and at 6 months for clinical response
Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
C
Christina Chesnakov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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