- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02441153
Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy (T4RC)
T4RC North: Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy; Does a Longer Wait Improve Outcomes?
Study Overview
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: Antonio Caycedo, MD. M.Sc (c). FRCS. FACS, Health Sciences North
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T4RC North
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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