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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-08-20

No results posted yet for this study

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

Interventions

RADIATION

Hypofractionated Radiation Therapy

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.

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Principal Investigators

  • Christopher L Anker, MD · University of Vermont Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2029-05-31
Primary Completion
2039-05-31
Completion
2040-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07775209 on ClinicalTrials.gov