Locally Advanced Rectal CancerNCT03238885
Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics
An observational study of Locally Advanced Rectal Cancer, run by Sun Ying-Shi at 1 site in China.
Trial summary
This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- pelvic MR examination
- Type of treatment
- Injection or infusion
- How many people
- 538 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 21 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: LARC patients who will undergo neoadiuvant CRT before surgery.
Who may be able to join
- pathologically proved rectal cancer
- locally advanced rectal cancer (≥T3 or N+)
- a distance less than 12cm between the lower edge of tumor and the anal margin
- no evidence of distant metastases
- no prior anti-cancer therapy before treatment
- scheduled to receive preoperative CRT
Who cannot join
- history or concurrent of other malignancy
- incomplete preoperative CRT
- failed to receive surgery or unavailable pCR assessment
- poor quality of MR images for measurement
- patient quit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method
This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.
Read the detailed description
We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- pelvic MR examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic MR examinationDiagnostic test
All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.
| Study group | Role | What they receive |
|---|---|---|
| LARC-CRT | LARC patients who will receive neoadjuvant CRT before surgical resection. Receives: Diagnostic Test: pelvic MR examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response(pCR)
Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.
Measured: within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2017
- Study start1 Mar 2013
- Primary completion18 Dec 2018
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal CancerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Ying-Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Ying-Shi, Peking University Cancer Hospital & Institute
- Investigators
- Ying-Shi Sun, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03238885
- Sponsor's protocol ID
- RCpCR-MR-Radiomics
- Status last verified
- Jan 2019
- First submitted
- 1 Aug 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method
- ClinicalTrials.gov ID
- NCT03238885
- Acronym / sponsor ID
- RCpCR-MR-Radiomics
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Sun Ying-ShiUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 3 Aug 2017 (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 plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.
Detailed description
We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LARC-CRT | – | Diagnostic Test: pelvic MR examinationLARC patients who will receive neoadjuvant CRT before surgical resection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- LARC patients who will undergo neoadiuvant CRT before surgery.
Key inclusion criteria (6 listed)
- pathologically proved rectal cancer
- locally advanced rectal cancer (≥T3 or N+)
- a distance less than 12cm between the lower edge of tumor and the anal margin
- no evidence of distant metastases
- no prior anti-cancer therapy before treatment
Key exclusion criteria (5 listed)
- history or concurrent of other malignancy
- incomplete preoperative CRT
- failed to receive surgery or unavailable pCR assessment
- poor quality of MR images for measurement
- patient quit
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 |
|---|---|---|
| pelvic MR examinationAll patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI. | Diagnostic test | LARC-CRT |
Primary outcome
Pathological complete response(pCR)
Time frame: within one week after surgery
Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.
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 4 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Ying-Shi Sun study chair
Peking University Cancer Hospital & Institute
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 Locally Advanced Rectal Cancer, run by Sun Ying-Shi 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 6 inclusion and 5 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 4 Feb 2019. 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?
Pathological complete response(pCR) (time frame: within one week 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 4 Feb 2019.