Study for Wait and Watch Suitable in Rectal Cancer
Recruiting · NCT06252142 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tata Memorial Centre
View the official record on ClinicalTrials.gov →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.
Who can take part
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
Where it is running
1 location listed.
- Tata Memorial centre - Mumbai, Maharashtra, India