NCT06050707RecruitingPhase 2
MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 18 Aug 2023
- Start date
- 29 Sept 2023
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- University Health Network, Toronto
- NCT number
- NCT06050707
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 29 Sept 2023 to the primary completion date, 1 Sept 2028
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Not yet recruiting |
| CHUM - Centre Hospitalier de l'Universite de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Medical College of Wisconsin Cancer Center Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
| Allegheny Health Network Coordinator of this site? Confirm its status | Pittsburgh | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.