Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06050707

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Led by University Health Network, Toronto · Updated on 2026-03-06

80

Participants Needed

4

Research Sites

257 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

M

Medical College of Wisconsin

Collaborating Sponsor

AI-Summary

What this Trial Is About

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

CONDITIONS

Official Title

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pathologically proven anal squamous cell carcinoma, including non-keratinizing histology such as basaloid or cloacogenic types
  • Clinical stage T1-4 N0-1 M0 according to UICC/AJCC 8th Edition
  • Eligible for definitive radiation therapy or chemoradiotherapy
  • At least 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Not Eligible

You will not qualify if you...

  • Previous chemotherapy, radiation therapy, or curative surgery (e.g., APR) for anal cancer
  • Prior radiation therapy to the abdomino-pelvic area overlapping with current treatment volume
  • History of another malignancy unless disease-free for at least 2 years and considered low risk for recurrence
  • Exceptions include cervical cancer in situ and basal or squamous cell skin cancers diagnosed and treated within 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Allegheny Health Network

Pittsburgh, Pennsylvania, United States, 15212

Not Yet Recruiting

2

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

3

Austin Health

Heidelberg, Victoria, Australia, 3084

Not Yet Recruiting

4

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2C1

Actively Recruiting

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Research Team

A

Ali Hosni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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