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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06050707

Collaborator

(none)

Enrollment

58.6

Anticipated Duration (Months)

Study Details

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.

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Sep 1, 2028

Anticipated Study Completion Date :

Sep 1, 2028

Outcome Measures

Primary Outcome Measures

Change in locoregional failure (LRF) at Year 2 [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

Presence of distant metastasis (DM) [5 years]
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Colostomy rate [5 years]
The presence of a colostomy until colostomy removal.
Disease free survival (DFS) [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.
Overall survival (OS) [5 years]
The time from the date of registration to the date of death for any cause.
Physician-reported toxicities [5 years]
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
Patient Reported Outcomes [5 years]
Using the Common Terminology Criteria of Adverse Events
Quality of life (QOL) [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.
Quality of life (QOL) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT06050707

Other Study ID Numbers:

23-5323

First Posted:

Sep 22, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anus Neoplasms

Study Results

No Results Posted as of Sep 22, 2023