Rectal NeoplasmsT4RCNCT02441153
Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy
An observational study of Rectal Neoplasms, run by Health Sciences North Research Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Extended Timing
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to 25 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Neoplasms
- Being tested
- Extended Timing
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended TimingOther
Surgery will be performed at 10-11 weeks after completion of chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Extended Timing) | Surgery will be performed at 10-11 weeks after the completion of chemoradiotherapy. Receives: Other: Extended Timing | |
| Group 2 (Non-extended timing) | Surgery will be performed at 6-7 weeks after completion of chemoradiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
The absence of any local recurrence or metastatic disease discovered on physical exam, endoscopy, or imaging
Measured: 3 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMar 2016
- Primary completion25 Dec 2017
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Sciences North Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio E Caycedo, MD. M.Sc (c). FRCS. FACS, Principal investigator, Health Sciences North
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441153
- Sponsor's protocol ID
- T4RC North
- Acronym
- T4RC
- Status last verified
- Feb 2018
- First submitted
- 8 May 2015
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T4RC North: Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy; Does a Longer Wait Improve Outcomes?
- ClinicalTrials.gov ID
- NCT02441153
- Acronym / sponsor ID
- T4RC / T4RC North
- Conditions
- Rectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Health Sciences North Research InstituteUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Extended Timing) | – | Other: Extended TimingSurgery will be performed at 10-11 weeks after the completion of chemoradiotherapy. |
| Group 2 (Non-extended timing) | – | –Surgery will be performed at 6-7 weeks after completion of chemoradiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended TimingSurgery will be performed at 10-11 weeks after completion of chemoradiotherapy. | Other | Group 1(Extended Timing) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio E Caycedo, MD. M.Sc (c). FRCS. FACS principal investigator
Health Sciences North
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms, run by Health Sciences North Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.