A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rec
A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The study investigates and may propose a comprehensive, stage-specific, multimodal approach to rectal adenocarcinoma, with a foc
| Condition(s) | Rectal Adenocarcinoma, Non Metastatic |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | A phase II, single-center, non-profit, interventional study on patients affected by rectal adenocarcinoma. Patients will be stratified into three groups based on pre-treatment clinical stage. The study investigates and may propose a comprehensive, stage-specific, multimodal approach to rectal adenocarcinoma, with a focus on organ preservation even in early stages (cT1-2N0). When organ-sparing strategies are not feasible, the approach prioritizes minimally invasive techniques (laparoscopic and robotic) to reduce the physical, psychological, and quality-of-life impact on patients. |
| Who can participate | Inclusion Criteria: * Patients aged ≥18 yrs old * Patients able to sign the informed consent * Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised * Patients with cT2-3aN0 rectal adenocarcinoma who has complete/major response to EXPERIMENTAL CRT * Patients with cT3b4N0-1 rectal adenocarcinoma who has complete/major response to STANDARD CRT Exclusion Criteria: * cT2-4 any NM0 who don't reach cCR or cMR after experimental/standard CRT * Pregnancy |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione del Piemonte per l'Oncologia |
| Locations | Candiolo, Turin, Italy |
| Start date | 2024-04-30 |
| NCT ID | NCT06952101 |
| Official listing | https://clinicaltrials.gov/study/NCT06952101 |