Circumferential Resection MarginSCRM-01NCT03504449
Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial
A study testing neoadjuvant chemoradiotherapy in people with Circumferential Resection Margin and Intraoperative Perforation of Rectum, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum
- What is being tested?
- neoadjuvant chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Dec 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tumor within 12 cm of the anal verge
- T3N1-2 as determined by preoperative MRI examination
- negative circumferential resection margin determined by preoperative MRI examination
- Absence of distant metastases
- Absence of intestinal obstruction
Who cannot join
- With distant metastases
- With intestinal obstruction
- Pregnancy or lactation
- With operation contraindication
- With mental disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Jiagang Han, Professor, 8613522867841, hjg211@163.com
Jiagang Han, Professor
About this study
For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.
- Conditions
- Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum, Disease-free Survival, Overal Survival
- Being tested
- neoadjuvant chemoradiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemoradiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| surgery without neoadjuvant chemoradiotherapy | Experimental | For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy. Receives: Other: neoadjuvant chemoradiotherapy |
| surgery with neoadjuvant chemoradiotherapy | Experimental | For T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy. Receives: Other: neoadjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
circumferential resection margin
Measured: one week after operation
introperative perforation
Measured: During the operation
Secondary outcomes (4)
local recurrece
Measured: 3 years after operation
overal survival
Measured: 3 years after operation
disease-free survival
Measured: 3 years after operation
complications
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Dec 2016
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumferential Resection MarginStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Jun Wang, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504449
- Sponsor's protocol ID
- SCRM-01
- Acronym
- SCRM-01
- Status last verified
- Feb 2021
- First submitted
- 12 Apr 2018
- Last updated
- 8 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03504449
- Acronym / sponsor ID
- SCRM-01 / SCRM-01
- Conditions
- Circumferential Resection Margin, Intraoperative Perforation of Rectum, Local Recurrence of Malignant Tumor of Rectum, Disease-free Survival, Overal Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Apr 2018 (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.
For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery without neoadjuvant chemoradiotherapy | Experimental | Other: neoadjuvant chemoradiotherapyFor T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery without neoadjuvant chemoradiotherapy. |
| surgery with neoadjuvant chemoradiotherapy | Experimental | Other: neoadjuvant chemoradiotherapyFor T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, recieve surgery following neoadjuvant chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Tumor within 12 cm of the anal verge
- T3N1-2 as determined by preoperative MRI examination
- negative circumferential resection margin determined by preoperative MRI examination
- Absence of distant metastases
- Absence of intestinal obstruction
Key exclusion criteria (5 listed)
- With distant metastases
- With intestinal obstruction
- Pregnancy or lactation
- With operation contraindication
- With mental disorder
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 |
|---|---|---|
| neoadjuvant chemoradiotherapy | Other | surgery with neoadjuvant chemoradiotherapy, surgery without neoadjuvant chemoradiotherapy |
Primary outcome
circumferential resection margin
Time frame: one week after operation
introperative perforation
Time frame: During the operation
4 secondary outcomes
local recurrece
Time frame: 3 years after operation
overal survival
Time frame: 3 years after operation
disease-free survival
Time frame: 3 years after operation
complications
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neoadjuvant chemoradiotherapy in people with Circumferential Resection Margin and Intraoperative Perforation of Rectum, run by Beijing Chao Yang Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiagang Han, MD (+861085231604, wzhj611@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circumferential resection margin (time frame: one week after operation). The study lists 2 primary outcomes in all. 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 Feb 2021.