Active Surveillance and Chemotherapy Before Surgery for Stage II-III Rectal Cancer to Preserve Organs and Prevent Tumor Growth

What this Trial Is About

Researchers are evaluating how well active surveillance combined with chemotherapy before surgery works for treating people with stage II-III rectal cancer. This study aims to understand if delaying surgery after these treatments can better preserve organs and manage tumor growth. The trial also explores patient decision-making, communication with providers, and safety outcomes after treatment. Participants are assigned to one of two groups based on their response to treatment. Group I includes those who have a complete clinical response and undergo standard surgical removal of the rectum. Group II includes those with a complete response who receive active surveillance and additional chemotherapy for up to four months, with surgery reserved for tumor regrowth or incomplete response. Follow-up schedules differ between groups, with more frequent visits for Group II to monitor for disease progression. During the study, participants will undergo various assessments including physical exams, imaging scans like MRI, and quality of life questionnaires. Researchers will collect tissue samples to study treatment effects and biomarkers. Key outcomes measured include organ preservation rates, tumor regrowth, time to surgery or death, and long-term survival. Safety is monitored through recording adverse events, and participants are followed for up to five years to assess ongoing health and treatment impact.

Active Surveillance and Chemotherapy Before Surgery in Treating Participants With Stage II-III Rectal Cancer