Asian Watch-and-Wait Database (AWWD)
Recruiting · NCT06631443 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tata Memorial Centre
View the official record on ClinicalTrials.gov →What this trial is about
The standard treatment approach of localized rectal adenocarcinoma involves neoadjuvant radiotherapy and chemotherapy followed by assessment for surgery and optional adjuvant chemotherapy. However, such patients who achieve complete of near complete clinical response after neoadjuvant therapy are increasingly being managed with the 'Watch-and-Wait strategy' in the recent years. Although safety of such policy has been established, the patient population in the published studies are not represented well by Asian population. Moreover, the data about safety of such policy in the setting of modern neoadjuvant strategies is limited. The Principle Investigator propose a multinational collaborative prospective database study in Asia to systematically collect data on patients being managed with such a strategy. The target population is patients with localized rectal adenocarcinoma achieving near complete or complete response being managed by the Watch-and-Wait strategy. The primary end point being local regrowth and other survival and quality of life end points will be evaluated as well. A secure multinational database will be generated over 5 years with an estimated expected minimal sample size of 337 patients over 5 years across 7-10 Asian institutes to precisely evaluate the required endpoints. Ethical and legal requirements will be met at each participating institute.
Who can take part
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
Where it is running
1 location listed.
- Tata Memorial Centre - Mumbai, Maharashtra, India