Back to resultsMR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach (MAESTRO)
Primary Purpose
Anal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Radiotherapy - Low risk group
Radiotherapy - Standard risk group
Radiotherapy - Intermediate risk group
Radiotherapy - High risk group
Sponsored by
About this trial
This is an interventional treatment trial for Anal Squamous Cell Carcinoma
Eligibility 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.
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Presence of distant metastasis (DM)
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Colostomy rate
The presence of a colostomy until colostomy removal.
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.
Overall survival (OS)
The time from the date of registration to the date of death for any cause.
Physician-reported toxicities
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
Patient Reported Outcomes
Using the Common Terminology Criteria of Adverse Events
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.
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)
Full Information
NCT ID
NCT06050707
First Posted
August 18, 2023
Last Updated
October 3, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT06050707
Brief Title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Acronym
MAESTRO
Official Title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
September 1, 2028 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy - Low risk group
Intervention Description
20 fractions completed in 4 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy - Standard risk group
Intervention Description
25 fractions completed in 5 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy - Intermediate risk group
Intervention Description
30 fractions completed in 6 weeks
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy - High risk group
Intervention Description
35 fractions completed in 7 weeks
Primary Outcome Measure Information:
Title
Change in locoregional failure (LRF) at Year 2
Description
Any local or regional failure from the date of registration to the date of any of the local or regional failure.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Presence of distant metastasis (DM)
Description
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Time Frame
5 years
Title
Colostomy rate
Description
The presence of a colostomy until colostomy removal.
Time Frame
5 years
Title
Disease free survival (DFS)
Description
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.
Time Frame
5 years
Title
Overall survival (OS)
Description
The time from the date of registration to the date of death for any cause.
Time Frame
5 years
Title
Physician-reported toxicities
Description
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
Time Frame
5 years
Title
Patient Reported Outcomes
Description
Using the Common Terminology Criteria of Adverse Events
Time Frame
5 years
Title
Quality of life (QOL)
Description
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.
Time Frame
5 years
Title
Quality of life (QOL)
Description
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)
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Hosni
Phone
416-946-2360
Email
ali.hosni@uhn.ca
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Hosni, MD
Phone
416-946-2360
Email
ali.hosni.abdalaty@rmp.uhn.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
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