MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized
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 p
| Condition(s) | Anal Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Health Network, Toronto |
| Locations | Pittsburgh, Pennsylvania, United States; Milwaukee, Wisconsin, United States; Heidelberg, Victoria, Australia; Toronto, Ontario, Canada; Montreal, Quebec, Canada |
| Start date | 2023-09-29 |
| NCT ID | NCT06050707 |
| Official listing | https://clinicaltrials.gov/study/NCT06050707 |