Organ Preservation Strategy After Neoadjuvant Treatment for Stage II and III Rectal Cancer Evaluating Safety and Outcomes in Patients with Complete or Near Complete Response

What this Trial Is About

Researchers are evaluating organ preservation as a treatment strategy for patients with stage II and III locally advanced rectal cancer who show a complete or almost complete response to neoadjuvant treatment. The study aims to determine if this approach is feasible and safe, focusing on survival outcomes, local and distant relapse rates, and quality of life. The project seeks to implement this strategy within a clinical study setting to analyze its results in the local environment. Participants will first receive neoadjuvant chemoradiotherapy or radiotherapy, possibly combined with induction chemotherapy, according to clinical guidelines. Those with a complete response on MRI confirmed by endoscopy will be offered a watch and wait approach, while patients with an almost complete response on endoscopy will be offered transanal endoscopic microsurgery. Patients without these responses will undergo radical surgery. Patients opting for organ preservation will have a more intensive follow-up schedule, including regular MRI and endoscopy, compared to those who have radical surgery. During the study, participants will be closely monitored by medical records and undergo regular imaging and endoscopic assessments to evaluate response and detect any relapse. Key outcomes measured include the percentage of organ preservation strategies used, disease-free survival, overall survival, local and distant relapse rates, colostomy-free survival, and quality of life assessed at multiple time points up to five years. The total participation duration includes long-term follow-up to assess these outcomes and monitor patient well-being.

Organ Preservation in Locally Advanced Rectal Cancer