Study for Wait and Watch Suitable in Rectal Cancer (ARROW)

February 15, 2024 updated by: Tata Memorial Centre

Ambispective Observational Study for Locally Advanced Rectal Cancer Patients Suitable for Wait and Watch Treated With Total Neoadjuvant Therapy

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Locally Advanced Rectal Cancer Patients.

Description

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 with or without brachytherapy and completed TNT part of treatment (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

Exclusion Criteria:

  • Not eligible as per the above inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Successful organ preservation rate
Time Frame: 3 years.
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)
Time Frame: 3 years
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)
Time Frame: 3 years
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)
Time Frame: 3 years
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).
Time Frame: 3 yeasrs
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).
Time Frame: 3 years
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)
Time Frame: 3 years
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)
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local regrowth rates
Time Frame: 3 years
Percentage of patients developing local regrowth, earlier deemed complete or near complete clinical response
3 years
Total Mesorectal Excision rates
Time Frame: 3 years
Percentage of patients requiring TME-based surgical management.
3 years
Disease-free survival
Time Frame: 3 Years
From the date of start of treatment till the date of diagnosis of disease progression at any site
3 Years
Overall survival.
Time Frame: 3 years.
from the date of start treatment till date of death (any cause)
3 years.
Colostomy-free survival.
Time Frame: 3 years
From the date of start of treatment till the date of permanent colostomy procedure.
3 years
Total Mesorectal Excision free survival
Time Frame: 3 years
From the date of start of treatment till the date of TME-based surgery
3 years
Loco-regional control
Time Frame: 3 Years
Responce is assessed by comparing the presence or absence of disease between the baseline and response evaluation scan/scopy. Response evaluation will be done by clinical, radiological and endoscopic assessment and disease will be restaged with TNM.
3 Years
Treatment-related toxicities
Time Frame: 3 years
Acute and late treatment-related Gastro Intestinal, Genito Urinary or any other Common Terminology Criteria for Adverse Events toxicities of grade 3 or higher. Grade refers to the severity of the Adverse Events. And it graded as grade 1 is mild, grade 2 is moderate, grade 3 is severe, grade 4 is life-threatening consequences and grade 5 is death.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2024

Primary Completion (Estimated)

February 19, 2026

Study Completion (Estimated)

February 19, 2028

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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