Records outcomes of adults with rectal cancer monitored without immediate surgery
Collects data on Asian adults with localized rectal cancer managed by watch-and-wait.
Plain-language title generated from the registry record
Registry title: Asian Watch-and-Wait Database (AWWD)
Key facts
- Where
- Mumbai, IndiaSee the site
Where in India
- Tata Memorial CentreMumbai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Centre
- Trial code
- NCT06631443
- Record updated
- 20 November 2024
- Original description
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.Read full original descriptionShow less
Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
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.
Inclusion: 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: Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study; Recurrent rectal cancer; Not willing to consent for the study or to follow up routinely; Patients who cannot read or understand the language of QoL.