A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity
Recruiting · NCT06952101 · Interventional (participants receive a specific treatment) · Lead sponsor: Fondazione del Piemonte per l'Oncologia
View the official record on ClinicalTrials.gov →Interventions studied
Sparing ApproachStandard Chemotherapyexperimental chemoradiotherapy
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment - Candiolo, Turin, Italy