NCT06631443Recruiting
Asian Watch-and-Wait Database (AWWD)
Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
Source: ClinicalTrials.gov · Last updated 20 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 337 (estimated)
- First submitted
- 1 Oct 2024
- Start date
- 22 Oct 2024
- Primary completion date
- Oct 2029
- Lead sponsor
- Tata Memorial Centre
- Diseases
- Colorectal cancer
- NCT number
- NCT06631443
What you commit to
- Study type: Observational
- Planned participants: 337
- From 22 Oct 2024 to the primary completion date, Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.
Other illness
- Recurrent rectal cancer
Other
- Not willing to consent for the study or to follow up routinely
- Patients who cannot read or understand the language of QoL
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.