Rectal CancerNCT05496270
Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer
An observational study of Rectal Cancer, run by Sun Yat-sen University.
Trial summary
Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- total mesorectal excision
- Type of treatment
- Surgery or procedure
- How many people
- 1,509 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: T3 mid-low rectal cancer patients with clear MRF
Who may be able to join
- Eighteen- to eighty-year-old patients.
- T3 rectal cancer with clear mesorectal fascia (MRF),
- within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)
Who cannot join
- emergency surgery due to bleeding, perforation, and bowel obstruction,
- recurrent rectal cancer,
- inflammatory bowel disease,
- Stage IV.
About this study
Official title: Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study
Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total mesorectal excisionProcedure or surgery
Also called neoadjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| TME | patients only underwent TME Receives: Procedure: total mesorectal excision | |
| nCRT+TME | patients underwent TME following neoadjuvant treatment Receives: Procedure: total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year diseases free survival
Measured: 3 years after surgery
Secondary outcomes (4)
Margin-free （R0）resection rate
Measured: Immediately after the surgery
3-year overall survival rate
Measured: 3 years after surgery
Number of participants with surgical complications
Measured: 30 days after surgery
Local recurrence rate
Measured: 3 years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study startJan 2014
- Primary completionJan 2019
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496270
- Sponsor's protocol ID
- GIHSYSU-28
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The source data of the published results can be shared; they are available from the corresponding author upon reasonable request (kangl@mail.sysu.edu.cn).
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05496270
- Acronym / sponsor ID
- GIHSYSU-28
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,509 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 11 Aug 2022 (actual)
- 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.
Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TME | – | Procedure: total mesorectal excisionpatients only underwent TME |
| nCRT+TME | – | Procedure: total mesorectal excisionpatients underwent TME following neoadjuvant treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- T3 mid-low rectal cancer patients with clear MRF
Key inclusion criteria (3 listed)
- Eighteen- to eighty-year-old patients.
- T3 rectal cancer with clear mesorectal fascia (MRF),
- within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)
Key exclusion criteria (4 listed)
- emergency surgery due to bleeding, perforation, and bowel obstruction,
- recurrent rectal cancer,
- inflammatory bowel disease,
- Stage IV.
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 |
|---|---|---|
| total mesorectal excisionAlso: neoadjuvant treatment | Procedure or surgery | TME, nCRT+TME |
Primary outcome
3-year diseases free survival
Time frame: 3 years after surgery
4 secondary outcomes
Margin-free （R0）resection rate
Time frame: Immediately after the surgery
3-year overall survival rate
Time frame: 3 years after surgery
Number of participants with surgical complications
Time frame: 30 days after surgery
Local recurrence rate
Time frame: 3 years after the surgery
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 11 Aug 2022.
- Individual participant dataSharing planned: Undecided. The source data of the published results can be shared; they are available from the corresponding author upon reasonable request (kangl@mail.sysu.edu.cn).
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Sun Yat-sen University.
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 3 inclusion and 4 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 11 Aug 2022. 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?
3-year diseases free survival (time frame: 3 years after 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 11 Aug 2022.