Asian Watch-and-Wait Database (AWWD) (AWWD)

November 19, 2024 updated by: Shivakumar Gudi, Tata Memorial Centre

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Neoadjuvant radiation and chemotherapy followed by total mesorectal excision (TME) remains a standard approach in most of the centres globally. Although the oncological outcomes have improved significantly with this multimodality approach over the last few decades, this approach adversely affects quality of life and functional outcomes especially for those needing permanent colostomy. More recently, patients achieving complete or near complete response are increasingly being managed by the 'Watch-and-Wait' approach where in, patients are followed using an intense follow up protocol after radiation and chemotherapy and avoid or delay surgery(1)(2)(3)(4)(5). However, this approach has not been widely adopted worldwide and there is limited data in the published medical literature. While the randomized trials in this setting does not appear to be feasible for obvious ethical reasons, robust data collected both retrospectively and prospectively can provide insights into this approach and help us refine the Watch-and-Wait approach in our routine clinics and in optimizing patient selection and surveillance strategies. Such an attempt was done by developing a multinational database from the Netherlands, Brazil, Portugal, and the UK(6). This data base consisted of more than a thousand patients and several important clinical questions were answered using this data(7)(8). However, this database largely consisted of patients treated using long course chemoradiation which was considered a standard treatment previously at that time. Moreover, there was no representation from Asian countries in this database. Currently, with the recent publications from the large, randomized trials like RAPIDO, UNICANCER PRODIGE 23, OPRA, more and more patients with locally advanced non-metastatic rectal adenocarcinoma are managed with a total neoadjuvant therapy approach(9)(10)(11). Radiotherapy dose escalation using brachytherapy has also gained interest with recent publication of results from the OPERA trial(12). Hence, with these developments, management practice of locally advanced rectal adenocarcinomas has become heterogeneous across institutions globally. These patients are being treated with more aggressive neoadjuvant therapies including total neoadjuvant therapy (TNT) approach. Many of these regimens involve multiagent neoadjuvant chemotherapy in addition to chemoradiation or short course hypofractionated radiotherapy leading increased response rates. The knowledge about the risks and benefits of watch-and-wait strategy after newer neoadjuvant strategies is somewhat limited. It is not entirely known whether the watch-and-wait approach can be applied safely to these patients who achieve clinical complete response after more aggressive neoadjuvant therapy regimens. Also, the data on Asian patients managed with such a strategy is scarce in the literature. Not only the inherent biological and genetic factors associated with rectal adenocarcinoma in Asian patients may be different but also the compliance and feasibility of intense surveillance protocol can be challenging in some of the Asian countries. Considering all these, the principle investigator intend to develop a comprehensive and secure database exclusively from Asian countries and to collect meaningful data systematically to answer important clinical questions on watch-and-wait strategy in Asian patients. This effort is likely to strengthen available evidence on this subject and generate evidence based on data exclusively from Asian patients. Collective efforts from participating nations can facilitate mutual learning and help in safe adoption of the watch-and-wait strategy in a greater number of centres across Asia. This collaborative study among Asian countries may potentially pave the way for future studies of similar kind.

Study Type

Observational

Enrollment (Estimated)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Shivakumar Gudi, MBBS, MD (Radiation Oncology)
  • Phone Number: 6863 2224177000
  • Email: shivakumargudi@gmail.com

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Recruiting
        • Tata Memorial Centre
        • Contact:
          • Dr Shivakumar Gudi, MBBS, MD (Radiation Oncology)
          • Phone Number: 6863 + 91 022 24177000
          • Email: shivakumargudi@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with localized rectal adenocarcinoma being treated at hospitals or institutes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local regrowth rate
Time Frame: 2 years
To determine the local regrowth rates at 2 years in Asian patients managed with the watch-and-wait strategy after neoadjuvant therapy in rectal cancer.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival Rates
Time Frame: 2 years
Rates of overall survival at 2 years is measured as a time to event end point from the date of diagnosis to date of death from any cause
2 years
Overall Survival Rates
Time Frame: 5 years
Rates of overall survival at 5 years is measured as a time to event end point from the date of diagnosis to date of death from any cause
5 years
Evaluating Disease-Free Survival
Time Frame: 2 years
Disease free survival at 2 years is measured as a time to event end point from the date of diagnosis to date of relapse or death from any cause
2 years
Evaluating Disease-Free Survival
Time Frame: 5 years
Disease free survival at 5 years is measured as a time to event end point from the date of diagnosis to date of relapse or death from any cause
5 years
Colostomy-Free Survival
Time Frame: 2 years
Colostomy free survival at 2 years is measured as a time to event end point from the date of diagnosis to date of colostomy or date of death from any cause
2 years
Colostomy-Free Survival
Time Frame: 5 years
Colostomy free survival at 5 years is measured as a time to event end point from the date of diagnosis to date of colostomy or date of death from any cause
5 years
Assessing Clinical Complete Response
Time Frame: 2 years
Clinical complete response rates with respect to various neoadjuvant treatment approaches
2 years
Assessing Clinical Regrowth Rates
Time Frame: 2 years
Clinical regrowth rates with respect to various neoadjuvant treatment approaches
2 years
Quality of life Assesment (EORTC QOL30)
Time Frame: 2 years
To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.
2 years
Quality of life Assesment (EORTC QOL CR29)
Time Frame: 2 years
To determine Quality of life (QOL) of patients managed with Watch-and-wait policy.
2 years
Patient Compliance
Time Frame: 2 years
Compliance of these patients to recommended surveillance protocol
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Centre

Investigators

  • Principal Investigator: Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology), Tata Memorial Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 5, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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