NCT06252142 Study for Wait and Watch Suitable in Rectal Cancer
| NCT ID | NCT06252142 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tata Memorial Centre |
| Condition | Rectal Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-02 |
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 260 participants in total. It began in 2024-04-01 with a primary completion date of 2026-02.
⚠ 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
One of the standard treatment options offered to patients of locally advanced rectal cancer is neoadjuvant (treatment given before surgery) radiotherapy \& chemotherapy followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the wait and watch strategy is also an option. This is another standard treatment option for patients of locally advanced rectal cancers. In this, the patient is monitored after treatment completion. In this study, investigators are only going to observe the patient's response to treatment, monitor their side-effects due to treatment and assess their quality of life using standardized quality of life questionnaires. No additional tests or hospital visits will be required as a part of this study. The patient will be followed up, as per standard follow-up protocol, for at least 2 years after the completion of their treatment.
Eligibility Criteria
Inclusion Criteria: * Age more than 18 years. * Patients diagnosed with locally advanced rectal cancer and suitable for wait and watch as per international consensus guidelines \[3,1\] * Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plus Limited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involving a single organ) * Non-circumferential disease with CCL less than 7 cm * Lower - mid rectum starting upto 7 cm from Anal verge * Previously treated with the intent of wait-and-watch with TNT or LCRT with or without brachytherapy and completed TNT part of treatment till March 2024(for retrospective cohort). * Patients not consenting to ongoing interventional studies, such as the SCOTCH study or any future studies, will be considered and offered * Consent to be on standard regular follow-up and answer quality of life questionnaires * Patients on lost to follow up will be included if they have completed treatment and taking follow up locally, accepting telephonically to participate. Exclusion Criteria: * Not eligible as per the above inclusion criteria
Contact & Investigator
Rahul KRISHNATRY, MD
PRINCIPAL INVESTIGATOR
Tata Memorial Centre
Frequently Asked Questions
Who can join the NCT06252142 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Rectal Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06252142 currently recruiting?
Yes, NCT06252142 is actively recruiting participants. Contact the research team at krishnatry@gmail.com for enrollment information.
Where is the NCT06252142 trial being conducted?
This trial is being conducted at Mumbai, India.
Who is sponsoring the NCT06252142 clinical trial?
NCT06252142 is sponsored by Tata Memorial Centre. The principal investigator is Rahul KRISHNATRY, MD at Tata Memorial Centre. The trial plans to enroll 260 participants.