Colon CancerPhase 3OLCMECCNCT02682589
Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
A Phase 3 study testing Open surgery and Laparoscopic surgery in people with Colon Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Open surgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Apr 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suitable for curative surgery over 18 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Pathological diagnosis of adenocarcinoma;
- Tumor located between the cecum and sigmoid colon;
- Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
- Informed consent;
- No preoperative chemoradiotherapy;
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Who cannot join
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Conversion to laparotomy;
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show:
Show all 13Show fewer
- Tumor involves the surrounding organs and combined organ resection need to be done;
- distant metastasis;
- unable to perform R0 resection;
- Postoperative pathology of T1-T2 N0;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation: mechanic ileus, perforation.
- Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu province hospital
Nanjing, Jiangsu, 210029
Yueming Sun, 68136026, jssym@vip.sina.com
About this study
Official title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.
Read the detailed description
Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to be feasible and safe and holds many advantages when compared with traditional open surgery, such as reducing preoperative blood loss, alleviating postoperative pain and reducing complications and length of hospital stay. Whether laparoscopic CME could achieve an equivalent oncological outcome, especially for locally advanced malignancy, is still being discussed.
The purpose of this study is to determine the short and long outcomes of open and laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the 5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon, morbidity and mortality, local recurrence, overall survival, quality of life et al.
In this study, eligible patient will be randomly allocated to receive either open or laparoscopic CME surgery. Randomization will be performed centrally and be stratified for age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor of the laparoscopic CME.
The extent of resection according to CME principle is identical for both arms. CME involves the removal of the afflicted colon and its accessory lymphvascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a "medial-to-lateral" approach and a no-touch isolation are required .
Intraoperative pictures were taken at various stages, as were photographs of the postoperative specimen, which will be assessed by a third-party expert to qualify the surgery.
The baseline demographics and conditions as well as the perioperative and postoperative outcomes will be recorded through a prior designed format.
Our study is expected to last seven years, of which two years for recruiting patients, five years for follow-up. Patients are followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.
- Conditions
- Colon Cancer
- Being tested
- Open surgery, Laparoscopic surgery
- Keywords
- Complete Mesocolic Excision, locally advanced Colon Cancer, Laparoscopic
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgeryProcedure or surgery
A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.
Laparoscopic surgeryProcedure or surgery
3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.
| Study group | Role | What they receive |
|---|---|---|
| Open surgery | Active comparator | Patients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Receives: Procedure: Open surgery |
| Laparoscopic surgery | Experimental | Patients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis. Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: 5 years
Secondary outcomes (9)
overall survival
Measured: 5 years
recurrence-free survival
Measured: 5 years
local recurrence rate
Measured: 5 years
length of postoperative hospital stay
Length of postoperative hospital stay is defined as a duration between surgery and first discharge. An expected average is 10 days.
Measured: 30 days
early complication rate
Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day 30. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
Measured: 30 days
operative time
Measured: 1 day
completeness of the mesocolon of the specimen
A central review by pathologists to define the completeness of the mesocolon to be good, moderate or poor will be performed on the specimen photographs.
Measured: 1 day
number of lymph nodes retrieved
Measured: 1 day
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Compare the differences in postoperative quality of life of patients treated with these two regimens using EORTC QLQ-C30 questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Changhai Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Ruijin Hospital, RenJi Hospital, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fujian Medical University, First Affiliated Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Yueming Sun, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Fumin Zhang, Professor, Study director, Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682589
- Sponsor's protocol ID
- CRSYM201602
- Acronym
- OLCMECC
- Status last verified
- Jul 2016
- First submitted
- 4 Feb 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Clinical Trial to Investigate Open Versus Laparoscopic Complete Mesocolic Excision for Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT02682589
- Acronym / sponsor ID
- OLCMECC / CRSYM201602
- Conditions
- Colon Cancer
- Keywords
- Complete Mesocolic Excision, locally advanced Colon Cancer, Laparoscopic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,080 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- West China Hospital, Changhai Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Ruijin Hospital, RenJi Hospital, Shanghai Changzheng Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Fujian Medical University, First Affiliated Hospital of Chongqing Medical University
- Study start
- Apr 2016
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 15 Feb 2016 (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.
Randomized, multicenter, phase III trial to compare the short and long outcomes of laparoscopic CME with open CME in treating patients with locally advanced colon cancer.
Detailed description
Laparoscopic complete mesocolic excision (CME) in treating colon cancer has been reported to be feasible and safe and holds many advantages when compared with traditional open surgery, such as reducing preoperative blood loss, alleviating postoperative pain and reducing complications and length of hospital stay. Whether laparoscopic CME could achieve an equivalent oncological outcome, especially for locally advanced malignancy, is still being discussed.
The purpose of this study is to determine the short and long outcomes of open and laparoscopic CME for locally advanced colon cancer patients. The primary endpoint is the 5-year disease-free survival rate. Secondary endpoints include completeness of mesocolon, morbidity and mortality, local recurrence, overall survival, quality of life et al.
In this study, eligible patient will be randomly allocated to receive either open or laparoscopic CME surgery. Randomization will be performed centrally and be stratified for age, gender, T-stage, tumor location. Patients will be randomized in a 2:1 ratio, in favor of the laparoscopic CME.
The extent of resection according to CME principle is identical for both arms. CME involves the removal of the afflicted colon and its accessory lymphvascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. Type of anastomosis, location of auxiliary incision and drainage of surgical field are up to the discretion of the surgeon. In laparoscopic surgery, a "medial-to-lateral" approach and a no-touch isolation are required .
Intraoperative pictures were taken at various stages, as were photographs of the postoperative specimen, which will be assessed by a third-party expert to qualify the surgery.
The baseline demographics and conditions as well as the perioperative and postoperative outcomes will be recorded through a prior designed format.
Our study is expected to last seven years, of which two years for recruiting patients, five years for follow-up. Patients are followed up every 3 months for 2 year, every 6 months for 3 years postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgery | Active comparator | Procedure: Open surgeryPatients undergo open CME. A standard midline incision carefully protected is made through the abdominal wall and the abdominal cavity is explored. A colectomy with CME is performed with the removal of the afflicted colon and its accessory lymphovascular supply at their origins by resecting the colon and mesocolon in an intact envelope of visceral peritoneum and mesenteric fascia. |
| Laparoscopic surgery | Experimental | Procedure: Laparoscopic surgeryPatients undergo laparoscopic CME. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with carbon dioxide to allow access and visualization. The abdominal cavity is explored. A colectomy with CME is performed using laparoscopic-assisted techniques. A 6-8cm midline auxiliary incision is made for specimen extraction and anastomosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients suitable for curative surgery over 18 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Pathological diagnosis of adenocarcinoma;
- Tumor located between the cecum and sigmoid colon;
- Enhanced CT scan of chest, abdominal and pelvic cavity: preoperative assessment of tumor stage is T3-T4 N0 or T any N+ (according to the National Comprehensive Cancer Network(NCCN) clinical practice guidelines in oncology: colon cancer version 2.2015);there is no distant metastasis;
Key exclusion criteria (13 listed)
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Conversion to laparotomy;
- Simultaneous or simultaneous multiple primary colorectal cancer;
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 |
|---|---|---|
| Open surgeryA traditional midline incision is made through the abdominal wall and a colectomy with CME is performed. | Procedure or surgery | Open surgery |
| Laparoscopic surgery3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study. | Procedure or surgery | Laparoscopic surgery |
Primary outcome
disease-free survival
Time frame: 5 years
9 secondary outcomes
overall survival
Time frame: 5 years
recurrence-free survival
Time frame: 5 years
local recurrence rate
Time frame: 5 years
length of postoperative hospital stay
Time frame: 30 days
early complication rate
Time frame: 30 days
operative time
Time frame: 1 day
completeness of the mesocolon of the specimen
Time frame: 1 day
number of lymph nodes retrieved
Time frame: 1 day
postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- 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.
Fumin Zhang, Professor study director
Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Open surgery and Laparoscopic surgery in people with Colon Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 8 inclusion and 13 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 6 Jul 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yueming Sun, PhD (02568136026, jssym@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 5 years). 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 6 Jul 2016.