Colorectal CancerPhase 2NCT00788281
A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
A Phase 2 study testing laparoscopic surgery and open surgery in people with Colorectal Cancer, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- laparoscopic surgery and open surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Apr 2016
- Phase
- Phase 2
- 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
- Informed consent
- Pathologically confirmed adenocarcinoma
- Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003)
- Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)
- Tumor diameter less than 6cm
- Age 18-75 year
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- ECOG 0-2
- Predicted survival longer than 6 months
- Normal liver, renal, bone marrow function: (GPT less than 2 ULN，total bilirubin less than 1.5mg/dl，Cr less than 1.5 ULN，WBC more than 4×109/L，PLT more than 100×109/L)
- No previous history of gastrointestinal surgery
- No previous history of chemotherapy or radiotherapy
Who cannot join
- Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months
- Could not tolerant general anesthesia or surgery for other organ dis-function
- Allergy to chemotherapeutical agents in the protocol
- History of other malignant tumor within 5 years
- Severe mental disorder
- Continued systematic steroid therapy
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- Woman during pregnancy or lactation
- Under study of other clinical trial
- No compliance of the protocol
- Discovery of distant metastasis during surgery
- Postsurgery stage of I or IV tumors
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Department of General Surgery
Beijing, Beijing Municipality, 100050
zhongtao zhang, doctor
zhongtao zhang, doctor
About this study
Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.
- Conditions
- Colorectal Cancer
- Being tested
- laparoscopic surgery, open 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.
laparoscopic surgeryProcedure or surgery
surgery would be performed by laparoscope
open surgeryProcedure or surgery
surgery would be performed by traditional surgery.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | laparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 Receives: Procedure: laparoscopic surgery |
| B | Active comparator | open surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 Receives: Procedure: open surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival rate
Measured: 3 year
tumor residual rate of LRM and CRM
Measured: 1 week
operation mortality
Measured: 2 months
Secondary outcomes (10)
survival rate
Measured: 3 year
survival rate
Measured: 5 year
local recurrence rate
Measured: 5 year
operation time
Measured: at the end of operation
blood lost
Measured: during operation
analgesic dosage
Measured: 1,2 and 3 days post surgery
evacuating time
Measured: post surgery
operation morbidity
Measured: 2 months
transfer to open surgery
Measured: during operation
fee
Measured: peri-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2011 (estimated)
- Study completionApr 2016 (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.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Investigators
- zhongtao zhang, doctor, Principal investigator, beijing friendship hospital, department of general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788281
- Sponsor's protocol ID
- BJLS01
- Status last verified
- Nov 2008
- First submitted
- 7 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomised Controlled Study to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00788281
- Acronym / sponsor ID
- BJLS01
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 10 Nov 2008 (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.
Laparoscopic surgery has been widely accepted for its minimal invasion and safety. However, whether it has the same survival benefit as the traditional open surgery in Chinese population is still unknown. So we designed this study to evaluate the 3 year disease free survival rate in the laparoscopic group versus the open surgery group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: laparoscopic surgerylaparoscopic surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 |
| B | Active comparator | Procedure: open surgeryopen surgery plus postsurgery adjuvant chemotherapy of FOLFOX4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Informed consent
- Pathologically confirmed adenocarcinoma
- Pre-surgery image staging as (CT/MRI):T2-3,N0-2,M0,(TNM stage，AJCC，version of 2003)
- Single tumor locating at cecum, ascending colon, descending colon, sigmoid colon, rectosigmoid junction, rectum(distance from anal verge more than 7cm)
- Tumor diameter less than 6cm
Key exclusion criteria (11 listed)
- Severe and uncontrolled medical disease including unstable angina pectoris, cardiac infarction and cerebral attack in 6 months
- Could not tolerant general anesthesia or surgery for other organ dis-function
- Allergy to chemotherapeutical agents in the protocol
- History of other malignant tumor within 5 years
- Severe 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 |
|---|---|---|
| laparoscopic surgerysurgery would be performed by laparoscope | Procedure or surgery | A |
| open surgerysurgery would be performed by traditional surgery. | Procedure or surgery | B |
Primary outcome
disease free survival rate
Time frame: 3 year
tumor residual rate of LRM and CRM
Time frame: 1 week
operation mortality
Time frame: 2 months
10 secondary outcomes
survival rate
Time frame: 3 year
survival rate
Time frame: 5 year
local recurrence rate
Time frame: 5 year
operation time
Time frame: at the end of operation
blood lost
Time frame: during operation
analgesic dosage
Time frame: 1,2 and 3 days post surgery
evacuating time
Time frame: post surgery
operation morbidity
Time frame: 2 months
transfer to open surgery
Time frame: during operation
fee
Time frame: peri-operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
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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.
zhongtao zhang, doctor principal investigator
beijing friendship hospital, department of general surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing laparoscopic surgery and open surgery in people with Colorectal Cancer, run by Beijing Friendship 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 11 inclusion and 11 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 13 Nov 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 jin wang, doctor (86-10-63138712, zhangzht@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival rate (time frame: 3 year). The study lists 3 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 13 Nov 2008.