Study for Wait and Watch Suitable in Rectal Cancer

NCT06252142 | Recruiting

• 1 other identifier: 4307
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Neoplasms

Keywords

Rectal Cancer; Wait and Watch; SCRT; LCRT

Outcome Measures

Primary Outcomes (8)

• 1. Successful organ preservation rate

  Percentage of patient avoiding surgery at median of follow up of 3 years.

  3 years.

• European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CR29 (Colorectal)

  Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CR29 (Colorectal).

  3 years

• European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 (Cancer)

  Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of C30 (Cancer).

  3 years

• European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire SH22 (Sexual Health)

  Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of SH22 (Sexual Health)

  3 years

• European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire PRT 20 (Proctitis).

  Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of PRT 20 (Proctitis)

  3 yeasrs

• European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire CIPN 20 (Chemotherapy induced peripheral neuropathy).

  Quality of life Will be assessed using scoring manual of European Organisation For Research And Treatment Of Cancer of CIPN 20 (Chemotherapy induced peripheral neuropathy).

  3 years

• Low Anterior Resection Syndrome Score (LARS)

  The LARS score is a validated and frequently used tool measuring bowel dysfunction after sphincter sparing surgery for rectal cancer. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

  3 years

• International Prostate Symptom Score (IPSS)

  This health tool aims to collect and analyse the perceived symptoms of patients suffering from urinary tract dysfunctions and benign prostatic hyperplasia (BPH)..The overall score in the I-PSS ranges between 0 and 35, from asymptomatic to very symptomatic status.

  3 years

Secondary Outcomes (8)

• Local regrowth rates

  3 years

• Total Mesorectal Excision rates

  3 years

• Loco-regional control

  3 Years

• Disease-free survival

  3 Years

• Overall survival.

  3 years.

Study Arms (4)

Retrospective LCRT

Retrospective SCRT

Prospective LCRT

Prospective SCRT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally Advanced Rectal Cancer Patients.

You may qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial centre

Mumbai, Maharashtra, India

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Rahul KRISHNATRY, MD

  Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahul Krishnatry, MD

CONTACT

022-24177000; krishnatry@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: April 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)