Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-Wait Approach by Developing a Multinational Collaborative Database

What this Trial Is About

Researchers are evaluating the safety and outcomes of the 'Watch-and-Wait' approach in Asian patients with localized rectal adenocarcinoma who achieve a complete or near complete clinical response after neoadjuvant radiotherapy and chemotherapy. This observational study aims to build a multinational prospective database over five years, focusing on local regrowth rates as the primary outcome and assessing survival and quality of life among this population. The study addresses limited existing data on Asian patients and the impact of modern, more aggressive neoadjuvant therapies on this strategy. The study collects data from several Asian institutes, enrolling patients treated with various neoadjuvant regimens including total neoadjuvant therapy and radiotherapy dose escalation. Participants are managed using the Watch-and-Wait strategy, which involves intense follow-up without immediate surgery to monitor tumor response and avoid or delay surgical intervention. The database will include detailed information on clinical responses, treatment regimens, and patient compliance. Participants will undergo regular assessments including clinical evaluations, quality of life questionnaires (EORTC QOL30 and QOL CR29), and monitoring for local regrowth and survival outcomes over a period of at least two years. Researchers will evaluate disease-free survival, colostomy-free survival, and patient adherence to follow-up protocols. This study aims to generate robust evidence to guide the safe adoption of Watch-and-Wait strategies in Asian patients with rectal cancer, with ongoing data collection expected until 2029.

Asian Watch-and-Wait Database (AWWD)