Study for Wait and Watch Suitable in Rectal Cancer

Launched by TATA MEMORIAL CENTRE · Feb 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach called "watch and wait" for patients with locally advanced rectal cancer. After initial treatment with radiotherapy and chemotherapy, some patients may see their tumors shrink completely. Instead of proceeding with surgery right away, this study will monitor these patients closely to see how well they do without surgery. Researchers will keep track of any side effects from the treatment and ask patients about their quality of life using simple questionnaires. Importantly, participants won't need any extra tests or hospital visits beyond their standard follow-up care, which will last for at least two years.

To be eligible for this study, patients must be over 18 years old and have a specific type of rectal cancer that meets certain criteria, such as having tumors that are not too large and are located in a particular area of the rectum. Patients must also agree to regular follow-ups and answer questions about their quality of life. Overall, this trial aims to see if a careful monitoring approach can be a safe and effective option for patients who have responded well to their initial treatment.

Gender

ALL

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