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

Anal Squamous Cell Carcinoma Clinical Trial

— MAESTRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050707
• Other study ID #: 23-5323
• Status: Recruiting
• Phase: Phase 2
• Start date: September 29, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Ali Hosni
• Phone: 416-946-2360
• Email: ali.hosni[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Squamous Cell Carcinoma
• Anus Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Austin Health	Heidelberg	Victoria
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Allegheny Health Network	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Medical College of Wisconsin Cancer Center, Allegheny Health Network, Austin Health

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	Presence of distant metastasis (DM)	Clear clinical/radiographic evidence of distant metastases in the lung, bone, brain, liver or other distant sites.	5 years
Secondary	Colostomy rate	The presence of a colostomy until colostomy removal.	5 years
Secondary	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.	5 years
Secondary	Overall survival (OS)	The time from the date of registration to the date of death for any cause.	5 years
Secondary	Physician-reported toxicities	Using the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE) V.5.	5 years
Secondary	Patient Reported Outcomes	Using the Common Terminology Criteria of Adverse Events	5 years
Secondary	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.	5 years
Secondary	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)	5 years