Rectal CancerNCT02406118
Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal TME
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Transanal total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2015to 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging (c or yc): T0-3, N0-2, M0
- Rectal cancer located 3-12 cm from the anal verge
- ECOG performance status: 2 or less
- BMI: less than 30
Who cannot join
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
- History of prior colorectal cancer or inflammatory bowel disease
- Tumor size: more than 7cm in long diameter
- CRM: mesorectal fascia involvement or less than 1 mm on MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Read the detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
- Conditions
- Rectal Cancer
- Being tested
- Transanal total mesorectal excision
- Keywords
- transanal TME quality, CRM
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal total mesorectal excisionProcedure or surgery
Also called Laparoscopy-assisted transanal TME
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
| Study group | Role | What they receive |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Laparoscopy-assisted transanal total mesorectal excision Receives: Procedure: Transanal total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
TME quality & circumferential resection margin (CRM)
The quality of the mesorectum was determined using pathology reports and scored using three grades:
- Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing.
- Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles.
- Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
Measured: the day of trananal TME
Secondary outcomes (2)
30-day postoperative complications
Measured: 1 month after surgery
Number of harvested Lymph Nodes
Measured: the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start1 Mar 2015
- Primary completion1 Dec 2018
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
- Investigators
- Dae Kyung Sohn, Principal investigator, NCC,Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406118
- Sponsor's protocol ID
- NCC2015-0033
- Status last verified
- Sep 2021
- First submitted
- 25 Mar 2015
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.
PubMed 29624549
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
- ClinicalTrials.gov ID
- NCT02406118
- Acronym / sponsor ID
- NCC2015-0033
- Conditions
- Rectal Cancer
- Keywords
- transanal TME quality, CRM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 Apr 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.
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
Detailed description
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transanal total mesorectal excision | Experimental | Procedure: Transanal total mesorectal excisionLaparoscopy-assisted transanal total mesorectal excision |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age: 20-80 years
- biopsy-proven adenocarcinoma of the rectum
- clinical staging (c or yc): T0-3, N0-2, M0
- Rectal cancer located 3-12 cm from the anal verge
- ECOG performance status: 2 or less
Key exclusion criteria (8 listed)
- Synchronous colon cancer or other malignancy
- Obstructing rectal cancer
- Pregnant or breast-feeding
- Receiving any other study agents
- Fecal incontinence
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 |
|---|---|---|
| Transanal total mesorectal excisionAlso: Laparoscopy-assisted transanal TMESubjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer. | Procedure or surgery | Transanal total mesorectal excision |
Primary outcome
TME quality & circumferential resection margin (CRM)
Time frame: the day of trananal TME
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
2 secondary outcomes
30-day postoperative complications
Time frame: 1 month after surgery
Number of harvested Lymph Nodes
Time frame: the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Derived from this study: PubMed 29624549Park SC, Sohn DK, Kim MJ, Chang HJ, Han KS, Hyun JH, Joo J, Oh JH. Phase II Clinical Trial to Evaluate the Efficacy of Transanal Endoscopic Total Mesorectal Excision for Rectal Cancer. Dis Colon Rectum. 2018 May;61(5):554-560. doi: 10.1097/DCR.0000000000001058.
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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.
Dae Kyung Sohn principal investigator
NCC,Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal total mesorectal excision in people with Rectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 8 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 10 Sep 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 South Korea. 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?
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?
TME quality & circumferential resection margin (CRM) (time frame: the day of trananal TME). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406118, which also lists 1 linked publication.
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 10 Sep 2021.