Asian Watch-and-Wait Database (AWWD)

Launched by TATA MEMORIAL CENTRE · Oct 5, 2024

Keywords

ClinConnect Summary

The Asian Watch-and-Wait Database (AWWD) is a clinical trial studying a new approach for patients with localized rectal cancer, specifically rectal adenocarcinoma. Traditionally, these patients receive treatments like radiation and chemotherapy followed by surgery. However, some patients who show a strong response to these treatments may be able to skip surgery and instead be monitored closely—a strategy known as "Watch-and-Wait." This trial aims to gather important information about this approach, specifically for Asian patients, to better understand its safety and effectiveness.

To participate in this trial, individuals need to be at least 18 years old and have a confirmed diagnosis of rectal adenocarcinoma at a certain stage (T1-T4). They should have undergone previous treatment and achieved a complete or nearly complete response. Patients who join the study will be monitored for signs of cancer regrowth and their overall quality of life over five years. It's important to note that those with recurrent cancer or certain health conditions may not be eligible. This study will help fill the gap in knowledge about the Watch-and-Wait strategy in Asian populations, and participants will contribute to valuable research that could improve future treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed diagnosis of adenocarcinoma of the rectum
• • Age ≥18 years
• • Clinical stage T1-T4, N0-N2, M0 at diagnosis
• • ECOG Performance status 0-1
• • Neoadjuvant treatment with either short course or long course radiation therapy and / or chemotherapy
• • Complete or near complete clinical response after neoadjuvant therapy
• • Patients willing to be on watch-and-wait strategy.
• • The distance from anal verge of tumor up to 10 cm (Mid and low rectal tumors)
• Exclusion Criteria:
• • Recurrent rectal cancer
• • Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
• • Not willing to consent for the study or to follow up routinely
• • Patients who cannot read or understand the language of QoL