Study for Wait and Watch Suitable in Rectal Cancer

Last updated: April 7, 2025
Sponsor: Tata Memorial Centre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Digestive System Neoplasms

Rectal Cancer

Treatment

Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose

Clinical Study ID

NCT06252142
4307
  • Ages 18-90
  • All Genders

Study 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

Inclusion Criteria:

  • Age more than 18 years.

  • Patients diagnosed with locally advanced rectal cancer and suitable for wait andwatch as per international consensus guidelines [3,1]

  • Biopsy-proven adenocarcinoma (non-signet or non-mucinous) T1-4a or N0-2, plusLimited metastatic disease (metastases in 1to 2 organs OR 1to 2 metastases involvinga 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 orwithout brachytherapy and completed TNT part of treatment till March 2024(forretrospective cohort).

  • Patients not consenting to ongoing interventional studies, such as the SCOTCH studyor any future studies, will be considered and offered

  • Consent to be on standard regular follow-up and answer quality of lifequestionnaires

  • Patients on lost to follow up will be included if they have completed treatment andtaking follow up locally, accepting telephonically to participate.

Exclusion

Exclusion Criteria:

  • Not eligible as per the above inclusion criteria

Study Design

Total Participants: 260
Treatment Group(s): 1
Primary Treatment: Short Course radiotherapy based total neoadjuvant treatment +/- brachytherapy boost dose
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
June 30, 2026

Study Description

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.

Connect with a study center

  • Tata Memorial centre

    Mumbai, Maharashtra
    India

    Active - Recruiting

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