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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06050707




Registration number
NCT06050707
Ethics application status
Date submitted
18/08/2023
Date registered
22/09/2023

Titles & IDs
Public title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Scientific title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Secondary ID [1] 0 0
23-5323
Universal Trial Number (UTN)
Trial acronym
MAESTRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anal Squamous Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Anal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Radiotherapy - Low risk group
Treatment: Other - Radiotherapy - Standard risk group
Treatment: Other - Radiotherapy - Intermediate risk group
Treatment: Other - Radiotherapy - High risk group

Treatment: Other: Radiotherapy - Low risk group
20 fractions completed in 4 weeks

Treatment: Other: Radiotherapy - Standard risk group
25 fractions completed in 5 weeks

Treatment: Other: Radiotherapy - Intermediate risk group
30 fractions completed in 6 weeks

Treatment: Other: Radiotherapy - High risk group
35 fractions completed in 7 weeks
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in locoregional failure (LRF) at Year 2
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Presence of distant metastasis (DM)
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Colostomy rate
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Disease free survival (DFS)
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Physician-reported toxicities
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Patient Reported Outcomes
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Quality of life (QOL)
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Quality of life (QOL)
Timepoint [8] 0 0
5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
United States of America
State/province [2] 0 0
Wisconsin
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
University Health Network, Toronto
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical College of Wisconsin Cancer Center, Allegheny Health Network, Austin Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ali Hosni
Address 0 0
Country 0 0
Phone 0 0
416-946-2360
Fax 0 0
Email 0 0
ali.hosni@uhn.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06050707