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Asian Watch-and-Wait Database (AWWD)

NCT06631443 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 337

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology) · Tata Memorial Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06631443 on ClinicalTrials.gov