Adaptive Radiation in Anal Cancer

NCT05838391 | Recruiting DMC FDA Device

• 1 other identifier: AAAU0074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Anal cancer; Adaptive radiation; Chemotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Time to plan and deliver treatment fractions.

  This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.

  Up to 6 weeks

Secondary Outcomes (2)

• Acute Treatment Toxicity

  Up to 1 month post-treatment

• Complete Clinical Response Rate

  6 months following the completion of chemoradiation

Study Arms (1)

Chemotherapy and Adaptive Radiation Treatment Planning

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).

Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery; Drug: Mitomycin-C; Drug: 5-Fluorouracil; Drug: Capecitabine

Interventions

Mitomycin-C DRUG

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.

Chemotherapy and Adaptive Radiation Treatment Planning

5-Fluorouracil DRUG

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.

Also known as: 5-FU

Chemotherapy and Adaptive Radiation Treatment Planning

Capecitabine DRUG

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.

Also known as: Xeloda

Chemotherapy and Adaptive Radiation Treatment Planning

Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery RADIATION

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.

Also known as: Adaptive RT Planning and Delivery

Chemotherapy and Adaptive Radiation Treatment Planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Parturition; Mitomycin; Fluorouracil; Capecitabine

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Uracil; Pyrimidinones; Pyrimidines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Lisa Kachnic, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Chesnakov

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chu H. Chang Professor of Radiation Oncology; Chair, Department of Radiation Oncology

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 1, 2023
• Study Start: May 18, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

US (1)