RecruitingNCT06631443

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.


Sponsor

Tata Memorial Centre

Enrollment

337 participants

Start Date

Oct 22, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (Asian Watch-and-Wait Database, AWWD) is collecting data on rectal cancer patients in Asia who responded so well to pre-surgery treatment (chemotherapy and/or radiation) that their tumors largely or completely disappeared — allowing them to potentially avoid surgery through a "watch and wait" approach. **You may be eligible if...** - You have confirmed rectal cancer (adenocarcinoma) - You are 18 or older - Your tumor is in the lower or mid rectum (within 10 cm of the anal opening) - You received pre-surgery radiation or chemotherapy - Your tumor showed a complete or near-complete response to treatment - You are willing to undergo a "watch and wait" strategy instead of immediate surgery **You may NOT be eligible if...** - You have recurrent rectal cancer - You are unwilling or unable to attend regular follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Tata Memorial Centre

Mumbai, Maharashtra, India

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NCT06631443


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