Colorectal CancerPhase 3NCT02248038
A Multicenter Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery
A Phase 3 study testing open surgery and laparoscopic surgery in people with Colorectal Cancer, run by Cai Kailin at 1 site in China.
Trial summary
The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Colorectal 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
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Jun 2019
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- informed consent
- single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
- cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
- age less than 80 years old
- normal blood routine test and hepatic or renal function test
- no gastrointestinal surgery history or chemotherapy, radiation, No complete obstruction.
Who cannot join
- severe comorbidity such as heart attack or stroke, malignance in 5 years
- can not tolerate to general anesthesia, pneumoperitoneum or surgery
- pregnant or during breast-feeding period
- attending other clinical trial involving therapy
- cannot or disagree to attending the clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
The purpose of this study is to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
Read the detailed description
Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
Study design：Randomized parallel control
- Conditions
- Colorectal Cancer
- Being tested
- open surgery, laparoscopic surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open surgeryProcedure or surgery
Also called open
Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
laparoscopic surgeryProcedure or surgery
Also called laparoscopic
Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| open surgery | Active comparator | Conventional procedure Receives: Procedure: open surgery |
| laparoscopic surgery | Experimental | Minimum invasive procedure Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years diseases free survival rate
Measured: five years
5 years overall survival rate
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cai Kailin
- Sponsor type
- University, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Peking Union Medical College Hospital
- Responsible party
- Sponsor-investigator, Cai Kailin, Huazhong University of Science and Technology
- Investigators
- Guobin Wang, MD,PhD, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyKaixiong Tao, MD,PhD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyKailin Cai, MD,PhD, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyShi Wang, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248038
- Sponsor's protocol ID
- ChiCTR-TRC-14004767
- Other IDs
- ChiCTR-TRC-14004767
- Status last verified
- Sep 2014
- First submitted
- 9 Sep 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial on Laparoscopic Colorectal Cancer Surgery Compared With Open Surgery in China
- ClinicalTrials.gov ID
- NCT02248038
- Acronym / sponsor ID
- ChiCTR-TRC-14004767
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Cai KailinUniversity, hospital or other
- Collaborators
- Huazhong University of Science and Technology, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Peking Union Medical College Hospital
- Study start
- Jun 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 25 Sep 2014 (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 to verify the 5-year disease free survival (DFS) of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
Detailed description
Study type：Interventional Study phase：Phase III Objectives of Study：to verify the 5-year DFS of resectable colorectal cancer after laparoscopic surgery according to a Chinese Operative Standard was not inferior to open surgery.
Study design：Randomized parallel control
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 surgeryConventional procedure |
| laparoscopic surgery | Experimental | Procedure: laparoscopic surgeryMinimum invasive procedure |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- informed consent
- single colorectal adenocarcinoma, located at any segment of the colorectum with lower margin 5cm or more to the dental line
- cTNM：colon cancer T1-4N1-2M0，rectal cancer T1-3N1-2M0，longest diameter no more than 6cm
- age less than 80 years old
- normal blood routine test and hepatic or renal function test
Key exclusion criteria (5 listed)
- severe comorbidity such as heart attack or stroke, malignance in 5 years
- can not tolerate to general anesthesia, pneumoperitoneum or surgery
- pregnant or during breast-feeding period
- attending other clinical trial involving therapy
- cannot or disagree to attending the clinical trial
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 surgeryAlso: openPatients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients. | Procedure or surgery | open surgery |
| laparoscopic surgeryAlso: laparoscopicPatients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients. | Procedure or surgery | laparoscopic surgery |
Primary outcome
5 years diseases free survival rate
Time frame: five years
5 years overall survival rate
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Guobin Wang, MD,PhD study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Kaixiong Tao, MD,PhD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Kailin Cai, MD,PhD study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Colorectal Cancer, run by Cai Kailin 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: status not confirmed, as of the sponsor's last update on 25 Sep 2014. 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?
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?
5 years diseases free survival rate (time frame: five years). 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 25 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.