Recruiting

Adaptive Radiation

Sponsor:

Columbia University

Code:

NCT05838391

Conditions

Anal Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery

Mitomycin-C

5-Fluorouracil

Capecitabine

Study Details

Brief 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.

Conditions

Anal Squamous Cell Carcinoma

Study ID

NCT05838391

Start date

May 18, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Chemotherapy and Adaptive Radiation Treatment Planning

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).

Interventions

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.

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.

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.

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.

Primary outcome measure

  • Time to plan and deliver treatment fractions. [ Time Frame: Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Christina Chesnakov

646-317-4244cc4047@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Christina Chesnakov

cc4047@cumc.columbia.edu

Principal Investigator:

Lisa Kachnic, MD

More Information

Sponsor

Columbia University

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Anal cancer
  • Adaptive radiation
  • Chemotherapy
  • Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-03.