A Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

cT2-4 any NM0 who don't reach cCR or cMR after experimental/standard CRT

Pregnancy

Trial design

Treatments tested in this trial

  • Sparing Approach
  • experimental chemoradiotherapy
  • Standard Chemotherapy

Treatment groups

200 Participants
are divided into 3 treatment groups