Actively Recruiting
Study for Wait and Watch Suitable in Rectal Cancer
Led by Tata Memorial Centre · Updated on 2025-04-10
260
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study for Wait and Watch Suitable in Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age more than 18 years
- Diagnosed with locally advanced rectal cancer suitable for wait and watch as per international consensus guidelines
- Biopsy-proven adenocarcinoma (non-signet or non-mucinous), stages T1-4a or N0-2, with limited metastatic disease (metastases in 1 to 2 organs or 1 to 2 metastases in a single organ)
- Non-circumferential disease with circumferential clinical location less than 7 cm
- Tumor located in lower to mid rectum up to 7 cm from the anal verge
- Previously treated with intent of wait and watch using total neoadjuvant therapy (TNT) or long-course radiotherapy (LCRT) with or without brachytherapy and completed TNT by March 2024 (for retrospective patients)
- Not participating in ongoing interventional studies like the SCOTCH study or future studies
- Consent to standard follow-up and answering quality of life questionnaires
- Patients lost to follow-up included if they have completed treatment and are following up locally with telephonic consent
You will not qualify if you...
- Not eligible according to the above inclusion criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tata Memorial centre
Mumbai, Maharashtra, India
Actively Recruiting
Research Team
R
Rahul Krishnatry, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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