Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy (T4RC)

August 16, 2019 updated by: Health Sciences North Research Institute

T4RC North: Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy; Does a Longer Wait Improve Outcomes?

This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be identified and screened for inclusion into the study once referred to a general or colorectal surgeon for resection of their rectal cancer. This may occur before or after preoperative chemoradiotherapy (CRT) but randomization will take place after CRT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main question of this study is whether or not delaying surgery after preoperative CRT increases disease-free survival. The standard 6-7 week waiting period will be compared to 10-11 weeks, which was the time-frame identified in the Dutch Surgical Colorectal Audit as increasing the likelihood of pCR the most. This trial will also be able to determine if an increased waiting interval increases the rate of sphincter-preservation, local recurrence, and pCR. While similar to the GRECCAR-6 trial, our primary outcome is disease-free survival (a more clinically relevant outcome) and is the first North American clinical trial of this nature.

To maximize the utility of this trial, immunohistochemical staining will be performed on pre-CRT tumor samples to prospectively validate the scoring system proposed by Hur et al. [28] The question being whether or not expression of these biomarkers can predict which patients will experience pCR and disease-free survival.

The pilot will be constructed as a prospective, open-label clinical trial, with patients being randomized to undergo surgery at 6-7 weeks or 10-11 weeks after completion of preoperative CRT. The intention is that once preliminary data is available, other centres in Ontario will be recruited. This will not only help answer our research question, but also create a large, prospective database of rectal cancer patients. The Primary outcome (disease-free survival) will be assessed at 3 years.

Study Type

Observational

Enrollment (Actual)

50

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include patients at Health Sciences North who have been referred to a general or colorectal surgeon for resection of their rectal cancer.

Description

Inclusion Criteria:

  • Adult patients (>18 years)
  • T3/4N0M0 or TxN+M0 rectal cancer below or at the peritoneal reflection, confirmed on clinical exam, histology, pelvic MRI, and CT chest/abdo
  • Patients who have completed a CRT protocol for the above tumor at HSN
  • Informed consent given
  • Surgical resection with TME planned

Exclusion Criteria:

  • Metastatic disease
  • Failure to complete preoperative CRT
  • Unable to give free and informed consent
  • Unable to comply with the requirements of the study
  • Previous malignancy other than nonmelanoma skin cancer, papillary or follicular thyroid cancer
  • Inflammatory bowel disease
  • Hereditary colorectal cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1(Extended Timing)
Surgery will be performed at 10-11 weeks after the completion of chemoradiotherapy.
Surgery will be performed at 10-11 weeks after completion of chemoradiotherapy.
Group 2 (Non-extended timing)
Surgery will be performed at 6-7 weeks after completion of chemoradiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years post surgery
The absence of any local recurrence or metastatic disease discovered on physical exam, endoscopy, or imaging
3 years post surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Antonio Caycedo, MD. M.Sc (c). FRCS. FACS, Health Sciences North

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 (Actual)

March 1, 2016

Primary Completion (Actual)

December 25, 2017

Study Completion (Actual)

January 25, 2018

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

February 1, 2018

More Information

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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