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NCT Number: NCT06050707

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

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.

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Key information

Conditions

Anal Squamous Cell Carcinoma Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Austin Health, Heidelberg, Victoria, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiotherapy - Low risk group

Radiation

20 fractions completed in 4 weeks

Radiotherapy - Standard risk group

Radiation

25 fractions completed in 5 weeks

Radiotherapy - Intermediate risk group

Radiation

30 fractions completed in 6 weeks

Radiotherapy - High risk group

Radiation

35 fractions completed in 7 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Colostomy rate

    Time frame: 5 years

    The presence of a colostomy until colostomy removal.

  3. 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.

  4. Overall survival (OS)

    Time frame: 5 years

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

  5. Physician-reported toxicities

    Time frame: 5 years

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

  6. Patient Reported Outcomes

    Time frame: 5 years

    Using the Common Terminology Criteria of Adverse Events

  7. 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.

  8. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Hosni

CONTACT

[email protected]

416-946-2360

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Acronym: MAESTRO

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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