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

March 5, 2026 updated by: University Health Network, Toronto
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a risk-stratified dose of treatment (radiation dose and chemotherapy number of cycles) based on predefined clinical and biological biomarkers for anal squamous cell carcinoma (SCC). Radiotherapy will be delivered on the MR-Linac for image-guided-radiation therapy (IGRT). Patients will be followed for up to 5 years after radiotherapy and be required to complete questionnaires and clinic visits. Patients have the option to complete blood and tissue samples during the study.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Not yet recruiting
        • Austin Health
        • Contact:
          • Ee Siang Choong, MD
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C1
  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Not yet recruiting
        • Allegheny Health Network
        • Contact:
          • Alexander Kirichenko, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin Cancer Center
        • Contact:
          • William A Hall, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with pathologically proven diagnosis of anal SCC. This may include tumors of non-keratinizing histology such as basoloid or cloacogenic histology. Individuals with squamous cell carcinoma of the anal margin are eligible.
  • Clinical stage T1-4 N0-1 M0 (the Union for International Cancer Control (UICC) / the American Joint Committee on Cancer (AJCC) 8th Ed)
  • Patients must be eligible for definitive RT or CRT
  • Must be ≥ 18 years of age
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

  • Previous chemotherapy, RT or curative-intent surgical treatment (i.e. APR) for anal cancer.
  • Any previous RT to the abdomino-pelvic region that would result in overlap of RT volume for the current study.
  • Individuals with a history of a different malignancy except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in locoregional failure (LRF) at Year 2
Time Frame: 2 years
Any local or regional failure from the date of registration to the date of any of the local or regional failure.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of distant metastasis (DM)
Time Frame: 5 years
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
5 years
Colostomy rate
Time Frame: 5 years
The presence of a colostomy until colostomy removal.
5 years
Disease free survival (DFS)
Time Frame: 5 years
The time from the date of registration to the date of first record of any of the following events including local, regional, distant failure, or death due to any cause.
5 years
Overall survival (OS)
Time Frame: 5 years
The time from the date of registration to the date of death for any cause.
5 years
Physician-reported toxicities
Time Frame: 5 years
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
5 years
Patient Reported Outcomes
Time Frame: 5 years
Using the Common Terminology Criteria of Adverse Events
5 years
Quality of life (QOL)
Time Frame: 5 years
Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-C30) questionnaire. The EORTC-C30 questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.
5 years
Quality of life (QOL)
Time Frame: 5 years
Based on the completion of the European Organisation For Research And Treatment Of Cancer (EORTC-AN27) questionnaire. EORTC QLQ-ANL27 includes four quality of life domains: pain, bowel, sexual and stoma care problems and five single item (frequent urination, keeping clean, proximity to toilet, lower limb oedema, planning activities)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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