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Study for Wait and Watch Suitable in Rectal Cancer | Clinical Trials | Clareo Health

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RECRUITINGNCT06252142

Study for Wait and Watch Suitable in Rectal Cancer

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 patient...

Lead sponsor: Tata Memorial Centre•1 locations•View source on ClinicalTrials.gov

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Contacts

Rahul Krishnatry, MD

CONTACT

022-24177000 [email protected]

Sponsors

Lead Sponsor

Tata Memorial Centre

The standard treatment options offered to patients of locally advanced rectal cancer are neoadjuvant (treatment given before surgery), radiotherapy \& chemotherapy, followed by surgery. In patients whose tumour has completely reduced after neoadjuvant treatment, the watch and wait or non-operative management is an option. In this, the patient is monitored after treatment completion. In this study, investigators will only 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. The patient will be followed up, as per standard follow-up protocol, for at least two years after the completion of their treatment.

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 10, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment260

Start dateApr 2024

Last updatedApr 10, 2025

Condition

Rectal Neoplasms

Locations shown

Tata Memorial centre

Mumbai, Maharashtra

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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