MR-guided radiation therapy for anal cancer with tailored treatment

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

This study is testing a personalized radiation therapy approach for patients with anal cancer to see if adjusting treatment based on their individual risk levels and biomarkers can improve their outcomes.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 4 sites (Pittsburgh, Pennsylvania and 3 other locations)
• Trial ID: NCT06050707 on ClinicalTrials.gov

What this trial studies

This phase II, single-arm, open-label trial investigates the use of MR-guided radiation therapy for patients with anal squamous cell carcinoma, employing a risk-adaptive approach to determine radiation doses and chemotherapy cycles based on clinical and biological biomarkers. Patients will be categorized into four risk groups: low, standard, intermediate, and high risk, and will receive tailored treatment accordingly. The study will analyze HPV DNA to identify biomarkers that predict responses to chemoradiotherapy and associated toxicities. Participants will be monitored for up to five years post-treatment, with opportunities for blood and tissue sampling.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed anal squamous cell carcinoma who are eligible for definitive radiation or chemoradiation therapy.

Not a fit: Patients with a history of previous chemotherapy, radiation therapy, or curative surgical treatment for anal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with anal cancer.

How similar studies have performed: Other studies utilizing risk-adaptive treatment approaches have shown promise, suggesting potential for success in this novel application.

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.

Where this trial is running

Pittsburgh, Pennsylvania and 3 other locations

• Allegheny Health Network — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
• Medical College of Wisconsin Cancer Center — Milwaukee, Wisconsin, United States (Not_yet_recruiting)
• Austin Health — Heidelberg, Victoria, Australia (Not_yet_recruiting)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Ali Hosni

Conditions Anal Squamous Cell Carcinoma