Rectal CancerNCT05609149
MRI Features in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer
An observational study of Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the… 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
- 480 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2016to 2 Nov 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: Rectal cancer patients with T3Nx or T1-3N+ at initial diagnosis.
Who may be able to join
- Underwent primary rectal adenocarcinoma resection
- Received MRI scan before surgery
- Willing and able to provide written informed consent for participation in this study.
- Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (<12 cm from the anal verge).
- Clinical stage of T3Nx or T1-3N+ at initial diagnosis
- Non-complicated primary tumor (complete obstruction, perforation, bleeding).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- Treated with transanal local excision
- with distant metastases at the time of initial diagnosis
- Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).
Trial locations and contacts
1 site in 1 country.
China1 site
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: Risk Criteria Based on MRI Features Outperform Radiographic TNM Staging in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer:A Single-Center, Open-Label, Retrospective, Observational Cohort Study
This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.
Read the detailed description
There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.
- Conditions
- Rectal Cancer
- Being tested
- total mesorectal excision
- Keywords
- Rectal cancer, Neoadjuvant treatment, Mesorectal fascia, Extramural vascular invasion
- 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
patients must underwent total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| T3 Rectal cancer | Patients with T3 rectal cancer who underwent curative surgery. Receives: Procedure: total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year event-free survival rate
Measured: 3 years after the surgery
Secondary outcomes (2)
3-year overall survival rate
Measured: 3 years after the surgery
Local recurrence
Defined as an intrapelvic recurrence following a primary rectal cancer resection, with or without distal metastasis.
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 posted8 Nov 2022
- Study start30 Oct 2016
- Primary completion1 Nov 2022
- Study completion2 Nov 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
- 480 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
- NCT05609149
- Sponsor's protocol ID
- GIHSYSU-30
- Status last verified
- Nov 2022
- First submitted
- 4 Nov 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous data may be provided upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Criteria Based on MRI Features Outperform Radiographic TNM Staging in Neoadjuvant Treatment Decisions for Patients With Rectal Cancer:A Single-Center, Open-Label, Retrospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05609149
- Acronym / sponsor ID
- GIHSYSU-30
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Neoadjuvant treatment, Mesorectal fascia, Extramural vascular invasion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 8 Nov 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.
This study investigates whether risk criteria based on MRI features could identify a cohort of patients with a good prognosis among those recommended for preoperative treatment by NCCN guidelines to avoid preoperative treatment with the likely good survival outcomes by primary surgery and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatmen than radiographic TNM staging in the patients who received neoadjuvant therapy.
Detailed description
There is a lack of international consensus on the choice of preoperative treatment for patients with rectal cancer. Existing guidelines decide whether to administer preoperative therapy to patients with rectal cancer mainly based on the TNM system developed by AJCC/UICC, however, radiographic TNM staging is unsatisfactory in predicting the prognosis of patients with rectal cancer, due to inflammatory and fibrotic responses TNM re-staging is less accurate than pre-treatment. Studies have shown that high-resolution magnetic resonance imaging(MRI) accurately predicted pathologic findings such as CRM involvement, EMVI and TD and patients with MRI-detected CRM involvement, EMVI and TD are at risk for local and distant recurrence as well as poor overall survival. This retrospective study is designed to was to evaluate whether risk criteria based on MRI features can be used as a basis for neoadjuvant treatment decisions and more accurately indicate the response to the treatment and predict prognosis after neoadjuvant treatment than radiographic TNM staging. Patients with MRI-detected circumferential resection margin (CRM) involvement, extramural venous invasion (EMVI), or tumor deposits (TD) were defined as MRI high-risk.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T3 Rectal cancer | – | Procedure: total mesorectal excisionPatients with T3 rectal cancer who underwent curative surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients with T3Nx or T1-3N+ at initial diagnosis.
Key inclusion criteria (7 listed)
- Underwent primary rectal adenocarcinoma resection
- Received MRI scan before surgery
- Willing and able to provide written informed consent for participation in this study.
- Treatment-naive patients with histological or cytological documentation of rectal adenocarcinoma (<12 cm from the anal verge).
- Clinical stage of T3Nx or T1-3N+ at initial diagnosis
Key exclusion criteria (4 listed)
- Treated with transanal local excision
- with distant metastases at the time of initial diagnosis
- Subjects with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.
- Subjects with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), myocardial infarction (MI), Transient Ischemic Attacks (TIA), or cerebralvascular accident (CVA).
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 excisionpatients must underwent total mesorectal excision | Procedure or surgery | T3 Rectal cancer |
Primary outcome
3-year event-free survival rate
Time frame: 3 years after the surgery
2 secondary outcomes
3-year overall survival rate
Time frame: 3 years after the surgery
Local recurrence
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 8 Nov 2022.
- Individual participant dataSharing planned: Undecided. Anonymous data may be provided upon reasonable request
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
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 7 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 event-free survival rate (time frame: 3 years after the 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 8 Nov 2022.