Personalized Multimodal Treatment for Rectal Adenocarcinoma Focusing on Organ Preservation and Minimally Invasive Surgery

What this Trial Is About

Researchers are evaluating a personalized, stage-related, multimodal treatment approach for patients with rectal adenocarcinoma. The study focuses on organ preservation, especially in early-stage tumors, and prioritizes minimally invasive techniques like laparoscopic and robotic surgery to reduce the physical and psychological impact on patients. This phase II, single-center, interventional study aims to improve quality of life while managing rectal cancer effectively. Patients are divided into three groups based on tumor stage before treatment. Group 1 includes patients with early-stage tumors who may undergo local excision or endoscopic resection followed by experimental chemoradiotherapy and a Watch and Wait strategy if surgery is declined. Group 2 involves patients with cT2N0 tumors offered an alternative experimental chemoradiotherapy approach with restaging to decide on organ-sparing strategies or local excision. Group 3 patients with more advanced tumors receive standard chemoradiotherapy and may be considered for organ-sparing methods if they respond well. If organ-sparing is not possible, minimally invasive surgery is performed with nerve preservation and enhanced recovery protocols. Participants undergo thorough imaging and diagnostic assessments including pelvic MRI, CT scans, PET, endorectal ultrasound, and rectoscopy for accurate staging and restaging. The study monitors clinical and pathological responses, quality of life, bowel function, and long-term disease outcomes. Close surveillance follows organ-preserving treatments. The primary outcome is development of a scoring system to predict complete tumor response. Participants are followed for several years to assess survival, quality of life, and bowel function after different treatment approaches.

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