Actively Recruiting
Adaptive Radiation in Anal Cancer
Led by Columbia University · Updated on 2026-02-03
20
Participants Needed
1
Research Sites
293 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
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.
CONDITIONS
Official 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
- AJCC 8th edition stage T2 > 4 cm, T3-4, or N1
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Life expectancy greater than 12 months
- Normal organ and marrow function including leukocytes ≥ 3,000/microliter, absolute neutrophil count ≥ 1,500/microliter, platelets ≥ 100,000/microliter
- Total bilirubin within normal limits
- AST/ALT ≤ 2.5 times institutional upper limit
- Normal creatinine or creatinine clearance ≥ 60 mL/min/1.73 m2
- Agreement to use adequate contraception during study and for 6 months after therapy
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Prior or co-existing invasive cancer unless disease-free for 2 or more years (except non-melanomatous skin cancer)
- Prior chemotherapy or radiation for anal cancer
- Complete surgical removal of anal cancer
- Presence of recurrent or metastatic disease
- Prior allergic reaction to 5-Fluorouracil or mitomycin C
- Presence of artificial organ prosthetics, pacemakers, or other implantable devices
- Prior pelvic radiotherapy overlapping planned treatment fields
- Uncontrolled illness including HIV with CD4 count less than 200 or symptomatic heart disease
- Women who are pregnant or lactating
AI-Screening
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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
CONTACT
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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