Database for managing rectal cancer patients with a watch-and-wait approach
Evaluation of Clinical Outcome in Asian Patients with Localized Rectal Adenocarcinoma Managed with Watch-and-wait Approach by Developing a Multinational Collaborative Database.
This study is trying to gather information from rectal cancer patients in Asia who are closely monitored after treatment to see if the watch-and-wait approach is safe and effective for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 337 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Centre Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06631443 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed localized rectal adenocarcinoma who have achieved a near complete or complete clinical response after neoadjuvant treatment.
Not a fit: Patients with recurrent rectal cancer or those with concurrent medical conditions that may affect their eligibility will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that improve the management and quality of life for rectal cancer patients who respond well to neoadjuvant therapy.
How similar studies have performed: While similar approaches have been successful in other regions, this study is novel in its focus on the Asian population and aims to fill a significant gap in the existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mumbai, Maharashtra
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.