NCT06050707 MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach
| NCT ID | NCT06050707 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Anal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2023-09-29 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06050707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06050707 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06050707 currently recruiting?
Yes, NCT06050707 is actively recruiting participants. Contact the research team at ali.hosni@uhn.ca for enrollment information.
Where is the NCT06050707 trial being conducted?
This trial is being conducted at Pittsburgh, United States, Milwaukee, United States, Heidelberg, Australia, Toronto, Canada and 1 additional location.
Who is sponsoring the NCT06050707 clinical trial?
NCT06050707 is sponsored by University Health Network, Toronto. The trial plans to enroll 80 participants.