Neoadjuvant Chemotherapy Before Surgery for Obstructive Colon Cancer Treated by Colostomy A Phase III Randomized Trial

What this Trial Is About

This research aims to determine if giving chemotherapy before surgery neoadjuvant chemotherapy can improve treatment outcomes for patients with non-metastatic obstructive colon cancer OCC who have had a colostomy to relieve obstruction. The study focuses on whether this approach increases the number of patients who complete the full recommended treatment, including surgery and chemotherapy, potentially improving prognosis by reducing tumor size and treating hidden cancer spread. This is a randomized phase III trial assessing this treatment strategy in patients with microsatellite stable MSS or proficient mismatch repair pMMR OCC. Participants will be randomly assigned to one of two groups. One group receives a diverting stoma followed by colectomy surgery and possibly adjuvant chemotherapy based on tumor stage and risk factors. The other group receives neoadjuvant chemotherapy with CAPOX or FOLFOX regimens for about three months, followed by surgery and potentially adjuvant chemotherapy depending on tumor analysis. Surgery is scheduled within days after randomization or chemotherapy completion, with treatments tailored by cancer stage and pathological features. During the trial, participants will undergo clinical assessments, imaging, and laboratory tests before and after treatments. Researchers will monitor treatment completion rates, surgical quality, adverse events, morbidity, mortality, and quality of life using questionnaires over 36 months. The primary outcome is the success of completing the full curative treatment sequence. Safety and effectiveness of neoadjuvant chemotherapy, along with surgical outcomes, will be evaluated to determine if this strategy improves care for obstructive colon cancer.

Neoadjuvant Chemotherapy for Obstructive Colon cancER First Treated by cOlostomy