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Anal Squamous Cell CarcinomaPhase 2MAESTRONCT06050707

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

A Phase 2 study testing Radiotherapy - Low risk group, Radiotherapy - Standard risk group and Radiotherapy - Intermediate risk group in people with Anal Squamous Cell Carcinoma, run by University Health Network, Toronto at 5 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Squamous Cell Carcinoma
What is being tested?
Radiotherapy - Low risk group, Radiotherapy - Standard risk group and Radiotherapy - Intermediate risk group
Type of treatment
Surgery or procedure
How many people
80 participants
Where
5 sitesin 3 countries
Study dates
29 Sep 2023to 1 Sep 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Ali Hosni contact

416-946-2360

ali.hosni@uhn.ca

5 sites in 3 countries

United States2 sites, 2 recruiting

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

    William A Hall, MD

    Not yet recruiting

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

    Alexander Kirichenko, MD

    Not yet recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • CHUM - Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0C1

    Mame Daro Faye, MD, 514 890-8254, mame.daro.faye.med@ssss.gouv.qc.ca

    Not yet recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2C1

    Ali Hosni, MD, 416-946-2360, ali.hosni.abdalaty@rmp.uhn.ca

    Recruiting

Other trials in Canada

Australia1 site, 1 recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Ee Siang Choong, MD

    Not yet recruiting

Other trials in Australia

About this study

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.

Read the 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.

Being tested
Radiotherapy - Low risk group, Radiotherapy - Standard risk group, Radiotherapy - Intermediate risk group, Radiotherapy - High risk group
Medical subject headings
Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiotherapy - Low risk groupRadiation

    20 fractions completed in 4 weeks

  • Radiotherapy - Standard risk groupRadiation

    25 fractions completed in 5 weeks

  • Radiotherapy - Intermediate risk groupRadiation

    30 fractions completed in 6 weeks

  • Radiotherapy - High risk groupRadiation

    35 fractions completed in 7 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in locoregional failure (LRF) at Year 2

    Any local or regional failure from the date of registration to the date of any of the local or regional failure.

    Measured: 2 years

Secondary outcomes (8)

  1. Presence of distant metastasis (DM)

    Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.

    Measured: 5 years

  2. Colostomy rate

    The presence of a colostomy until colostomy removal.

    Measured: 5 years

  3. Disease free survival (DFS)

    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.

    Measured: 5 years

  4. Overall survival (OS)

    The time from the date of registration to the date of death for any cause.

    Measured: 5 years

  5. Physician-reported toxicities

    Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.

    Measured: 5 years

  6. Patient Reported Outcomes

    Using the Common Terminology Criteria of Adverse Events

    Measured: 5 years

  7. Quality of life (QOL)

    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.

    Measured: 5 years

  8. Quality of life (QOL)

    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)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start29 Sep 2023
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050707
Sponsor's protocol ID
23-5323
Acronym
MAESTRO
Status last verified
Jun 2026
First submitted
18 Aug 2023
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy - Low risk group, Radiotherapy - Standard risk group and Radiotherapy - Intermediate risk group in people with Anal Squamous Cell Carcinoma, run by University Health Network, Toronto at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ali Hosni (416-946-2360, ali.hosni@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in locoregional failure (LRF) at Year 2 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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