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

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ClinicalTrials.gov Identifier: NCT06050707
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : October 6, 2023
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief 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. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

Condition or disease Intervention/treatment Phase
Anal Squamous Cell Carcinoma Radiation: Radiotherapy - Low risk group Radiation: Radiotherapy - Standard risk group Radiation: Radiotherapy - Intermediate risk group Radiation: Radiotherapy - High risk group Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Actual Study Start Date : September 29, 2023
Estimated Primary Completion Date : September 1, 2028
Estimated Study Completion Date : September 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer

Arms and Interventions
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Intervention Details:
  • Radiation: Radiotherapy - Low risk group
    20 fractions completed in 4 weeks
  • Radiation: Radiotherapy - Standard risk group
    25 fractions completed in 5 weeks
  • Radiation: Radiotherapy - Intermediate risk group
    30 fractions completed in 6 weeks
  • Radiation: Radiotherapy - High risk group
    35 fractions completed in 7 weeks

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050707


Contacts
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Contact: Ali Hosni 416-946-2360 ali.hosni@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact: Ali Hosni, MD    416-946-2360    ali.hosni.abdalaty@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT06050707    
Other Study ID Numbers: 23-5323
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: October 6, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anus Neoplasms
Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases