Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date last updated
13/06/2024
Titles & IDs
Public title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Query!
Scientific title
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Query!
Secondary ID [1]
0
0
23-5323
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MAESTRO
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Anal Squamous Cell Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Anal
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Change in locoregional failure (LRF) at Year 2
Query!
Assessment method [1]
0
0
Any local or regional failure from the date of registration to the date of any of the local or regional failure.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [1]
0
0
Presence of distant metastasis (DM)
Query!
Assessment method [1]
0
0
Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.
Query!
Timepoint [1]
0
0
5 years
Query!
Secondary outcome [2]
0
0
Colostomy rate
Query!
Assessment method [2]
0
0
The presence of a colostomy until colostomy removal.
Query!
Timepoint [2]
0
0
5 years
Query!
Secondary outcome [3]
0
0
Disease free survival (DFS)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
5 years
Query!
Secondary outcome [4]
0
0
Overall survival (OS)
Query!
Assessment method [4]
0
0
The time from the date of registration to the date of death for any cause.
Query!
Timepoint [4]
0
0
5 years
Query!
Secondary outcome [5]
0
0
Physician-reported toxicities
Query!
Assessment method [5]
0
0
Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.
Query!
Timepoint [5]
0
0
5 years
Query!
Secondary outcome [6]
0
0
Patient Reported Outcomes
Query!
Assessment method [6]
0
0
Using the Common Terminology Criteria of Adverse Events
Query!
Timepoint [6]
0
0
5 years
Query!
Secondary outcome [7]
0
0
Quality of life (QOL)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
5 years
Query!
Secondary outcome [8]
0
0
Quality of life (QOL)
Query!
Assessment method [8]
0
0
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)
Query!
Timepoint [8]
0
0
5 years
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Not applicable
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/09/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/09/2028
Query!
Actual
Query!
Sample size
Target
80
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Austin Health - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Pennsylvania
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Wisconsin
Query!
Country [3]
0
0
Canada
Query!
State/province [3]
0
0
Ontario
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University Health Network, Toronto
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Medical College of Wisconsin Cancer Center, Allegheny Health Network, Austin Health
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06050707
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Ali Hosni
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
416-946-2360
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
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
Download to PDF