Shortening Radiation Course Duration Using Simultaneous Integrated Boost With Lower Intensity Elective Nodal Dosing and Concurrent Chemotherapy for High-Risk Anal Squamous Cell Carcinoma

NCT07775209 | Enrolling By Invitation Phase 2 DMC

• 2 other identifiers: UVMCC2604temp
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2 single-arm study will evaluate whether a shortened course of mildly hypofractionated radiation therapy given with standard concurrent chemotherapy (mitomycin C and capecitabine) can provide acceptable tumor control in patients with high-risk non-metastatic anal squamous cell carcinoma. Standard chemoradiation for anal cancer typically requires approximately 5.5 to 6 weeks of daily radiation, which can create substantial logistical burden for patients and caregivers, particularly those in rural settings. The investigational approach uses a 23-fraction radiation regimen designed to shorten treatment duration while maintaining biologically equivalent tumor-directed dosing compared with standard treatment. The primary question is whether this shorter chemoradiation regimen can achieve an acceptable 6-month complete clinical response rate while maintaining manageable toxicity.

Conditions

Anal Cancer

Keywords

anal squamous cell carcinoma; Hypofractionated Radiation Therapy; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• Complete Clinical Response Rate at 6 Months

  Proportion of participants achieving complete clinical response, defined as absence of tumor and malignant ulceration in the anal canal and perianal skin on digital rectal examination and/or anoscopy, with resolution of palpable inguinal lymphadenopathy if present at baseline. Biopsy may be used when clinically indicated to confirm persistent disease.

  6 months after start of radiation therapy

Secondary Outcomes (16)

• Colostomy-Free Survival

  2 years

• Disease-Free Survival

  2 years

• Locoregional Control

  2 years

• Local Control Rate

  2 years

• Regional Control Rate

  2 years

Study Arms (1)

Experimental: Hypofractionated Chemoradiation

EXPERIMENTAL

Participants receive mildly hypofractionated radiation therapy delivered in 23 fractions using a simultaneous integrated boost approach with concurrent standard-of-care mitomycin C and capecitabine chemotherapy.

Radiation: Hypofractionated Radiation Therapy

Interventions

Hypofractionated Radiation Therapy RADIATION

Participants receive mildly hypofractionated radiation therapy delivered in 23 fractions using a simultaneous integrated boost approach, given concurrently with standard-of-care mitomycin C and capecitabine chemotherapy.

Experimental: Hypofractionated Chemoradiation

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Histologically or cytologically confirmed non-metastatic anal squamous cell carcinoma meeting one of the following criteria:
• T2 tumor measuring ≥4 cm T3 or T4 disease Any node-positive disease
• Patients with HPV-associated (p16-positive) perianal cancer are eligible if the tumor extends to the anal verge
• Karnofsky Performance Status \>60
• Creatinine clearance \>30 mL/min
• Considered by the investigator to be appropriate candidates for concurrent capecitabine and mitomycin C chemotherapy
• Ability to understand and willingness to provide informed consent
• For participants of childbearing potential: negative pregnancy test or documented absence of pregnancy per institutional standard within 14 days prior to registration
• Participants of reproductive potential must agree to use adequate contraception during study treatment and for 90 days after completion of therapy

You may not qualify if:

• Prior pelvic radiation therapy
• Uncontrolled intercurrent illness that, in the opinion of the investigator, would prevent safe receipt of radiation therapy or capecitabine
• Prior or concurrent malignancy that, in the opinion of the investigator, could interfere with assessment of safety or efficacy
• Current receipt of another investigational agent for treatment of anal squamous cell carcinoma

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Anus Neoplasms

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

Study Officials

• Christopher L Anker, MD

  University of Vermont Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist. Professor, Radiation-Oncology

Study Record Dates

• First Submitted: August 2, 2026
• First Posted: August 20, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): May 1, 2039
• Study Completion (Estimated): April 1, 2040
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)