| NCT ID | NCT06631443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Rectal Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 337 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 337 participants in total. It began in 2024-10-22 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology)
PRINCIPAL INVESTIGATOR
Tata Memorial Center
Frequently Asked Questions
Who can join the NCT06631443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06631443 currently recruiting?
Yes, NCT06631443 is actively recruiting participants. Contact the research team at shivakumargudi@gmail.com for enrollment information.
Where is the NCT06631443 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06631443 clinical trial?
NCT06631443 is sponsored by Tata Memorial Centre. The principal investigator is Shivakumar Gudi Dr., MBBS, MD (Radiation Oncology) at Tata Memorial Center. The trial plans to enroll 337 participants.