Database for managing rectal cancer patients with a watch-and-wait approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a multinational database to collect data on patients with localized rectal adenocarcinoma who achieve a near complete or complete clinical response after neoadjuvant therapy and are managed with a watch-and-wait strategy. The study will systematically gather information to better understand the safety and efficacy of this approach, particularly in the Asian population, which has been underrepresented in existing literature. By analyzing this data, the researchers hope to refine patient selection and surveillance strategies for those opting for the watch-and-wait method. The study will involve collaboration across multiple centers in Asia, focusing on improving outcomes for patients with rectal cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology) — Tata Memorial Center
• Study coordinator: Dr. Shivakumar Gudi, MBBS, MD (Radiation Oncology)
• Email: shivakumargudi@gmail.com
• Phone: 2224177000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.