Overall SurvivalNCT02942238
Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
A study testing CME and D3 in people with Overall Survival and Postoperative Complications, run by Ruijin Hospital.
Trial summary
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overall Survival, Postoperative Complications, Metastasis
- What is being tested?
- CME and D3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 582 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 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
- Patients suitable for curative surgery 18-75years old
- Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
- Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
- Informed consent
Who cannot join
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation;
- Not suitable for laparoscopic surgery;
- Women during Pregnancy or breast feeding period;
- Informed consent refusal
Trial locations and contacts
No sites are listed yet.
About this study
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.
- Being tested
- CME, D3
- Keywords
- CME, Right hemi Colon cancer, D3, laparoscopy
- Medical subject headings
- Postoperative Complications, Neoplasm Metastasis, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMEProcedure or surgery
the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed.
Intervention: Procedure: Complete mesocolic excision (CME)
D3Procedure or surgery
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels.
Intervention: Procedure: D3 radical operation
| Study group | Role | What they receive |
|---|---|---|
| Complete Mesocolic Excision | Experimental | the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck. Receives: Procedure: CME |
| D3 lymph node dissection | Active comparator | the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group. Receives: Procedure: D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 3 years
Secondary outcomes (4)
The rate of postoperative complications and mortality
Measured: 30 days
3 years overall survival
Measured: 3 years
The rate of local and distant recurrence
Measured: 3 years
The accuracy of preoperative staging with CT
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Overall SurvivalStudies of the same condition, open and under way.
- More trials run by Ruijin 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 582 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Responsible party
- Principal investigator, Minhua Zheng, Ruijin Hospital
- Investigators
- Minhua Zheng, PhD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942238
- Sponsor's protocol ID
- Ruijin-0002
- Status last verified
- Dec 2016
- First submitted
- 20 Oct 2016
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ostenfeld EB, Erichsen R, Iversen LH, Gandrup P, Norgaard M, Jacobsen J. Survival of patients with colon and rectal cancer in central and northern Denmark, 1998-2009. Clin Epidemiol. 2011;3 Suppl 1(Suppl 1):27-34. doi: 10.2147/CLEP.S20617. Epub 2011 Jul 21.
PubMed 21814467Laparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer Abstracted from: Nelson H, Sargent D, Wieand HS, et al; for the Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050-2059. Cancer Treat Rev. 2004 Dec;30(8):707-9. doi: 10.1016/j.ctrv.2004.09.001. No abstract available.
PubMed 15541580Kitano S, Inomata M, Sato A, Yoshimura K, Moriya Y; Japan Clinical Oncology Group Study. Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404. Jpn J Clin Oncol. 2005 Aug;35(8):475-7. doi: 10.1093/jjco/hyi124. Epub 2005 Jul 8.
PubMed 16006574Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.
PubMed 15894098Engstrom PF, Arnoletti JP, Benson AB 3rd, Chen YJ, Choti MA, Cooper HS, Covey A, Dilawari RA, Early DS, Enzinger PC, Fakih MG, Fleshman J Jr, Fuchs C, Grem JL, Kiel K, Knol JA, Leong LA, Lin E, Mulcahy MF, Rao S, Ryan DP, Saltz L, Shibata D, Skibber JM, Sofocleous C, Thomas J, Venook AP, Willett C; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: colon cancer. J Natl Compr Canc Netw. 2009 Sep;7(8):778-831. doi: 10.6004/jnccn.2009.0056. No abstract available.
PubMed 19755046West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
PubMed 22473170Kobayashi H, West NP, Takahashi K, Perrakis A, Weber K, Hohenberger W, Quirke P, Sugihara K. Quality of surgery for stage III colon cancer: comparison between England, Germany, and Japan. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S398-404. doi: 10.1245/s10434-014-3578-9. Epub 2014 Feb 25.
PubMed 24566862Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
PubMed 25555421Eiholm S, Ovesen H. Total mesocolic excision versus traditional resection in right-sided colon cancer - method and increased lymph node harvest. Dan Med Bull. 2010 Dec;57(12):A4224.
PubMed 21122462
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
- ClinicalTrials.gov ID
- NCT02942238
- Acronym / sponsor ID
- Ruijin-0002
- Keywords
- CME, Right hemi Colon cancer, D3, laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 582 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Study start
- Jan 2017
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Oct 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.
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Mesocolic Excision | Experimental | Procedure: CMEthe group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck. |
| D3 lymph node dissection | Active comparator | Procedure: D3the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suitable for curative surgery 18-75years old
- Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
- Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
- Informed consent
Key exclusion criteria (7 listed)
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation;
- Not suitable for laparoscopic surgery;
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 |
|---|---|---|
| CMEthe group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed. Intervention: Procedure: Complete mesocolic excision (CME) | Procedure or surgery | Complete Mesocolic Excision |
| D3the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels. Intervention: Procedure: D3 radical operation | Procedure or surgery | D3 lymph node dissection |
Primary outcome
Disease-free survival
Time frame: 3 years
4 secondary outcomes
The rate of postoperative complications and mortality
Time frame: 30 days
3 years overall survival
Time frame: 3 years
The rate of local and distant recurrence
Time frame: 3 years
The accuracy of preoperative staging with CT
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Results publication: PubMed 21814467Ostenfeld EB, Erichsen R, Iversen LH, Gandrup P, Norgaard M, Jacobsen J. Survival of patients with colon and rectal cancer in central and northern Denmark, 1998-2009. Clin Epidemiol. 2011;3 Suppl 1(Suppl 1):27-34. doi: 10.2147/CLEP.S20617. Epub 2011 Jul 21.
- Results publication: PubMed 15541580Laparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer Abstracted from: Nelson H, Sargent D, Wieand HS, et al; for the Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050-2059. Cancer Treat Rev. 2004 Dec;30(8):707-9. doi: 10.1016/j.ctrv.2004.09.001. No abstract available.
- Results publication: PubMed 16006574Kitano S, Inomata M, Sato A, Yoshimura K, Moriya Y; Japan Clinical Oncology Group Study. Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404. Jpn J Clin Oncol. 2005 Aug;35(8):475-7. doi: 10.1093/jjco/hyi124. Epub 2005 Jul 8.
- Results publication: PubMed 15894098Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.
- Results publication: PubMed 19755046Engstrom PF, Arnoletti JP, Benson AB 3rd, Chen YJ, Choti MA, Cooper HS, Covey A, Dilawari RA, Early DS, Enzinger PC, Fakih MG, Fleshman J Jr, Fuchs C, Grem JL, Kiel K, Knol JA, Leong LA, Lin E, Mulcahy MF, Rao S, Ryan DP, Saltz L, Shibata D, Skibber JM, Sofocleous C, Thomas J, Venook AP, Willett C; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: colon cancer. J Natl Compr Canc Netw. 2009 Sep;7(8):778-831. doi: 10.6004/jnccn.2009.0056. No abstract available.
- Results publication: PubMed 22473170West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
- Results publication: PubMed 24566862Kobayashi H, West NP, Takahashi K, Perrakis A, Weber K, Hohenberger W, Quirke P, Sugihara K. Quality of surgery for stage III colon cancer: comparison between England, Germany, and Japan. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S398-404. doi: 10.1245/s10434-014-3578-9. Epub 2014 Feb 25.
- Results publication: PubMed 25555421Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
- Results publication: PubMed 21122462Eiholm S, Ovesen H. Total mesocolic excision versus traditional resection in right-sided colon cancer - method and increased lymph node harvest. Dan Med Bull. 2010 Dec;57(12):A4224.
- 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.
Minhua Zheng, PhD study director
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A study testing CME and D3 in people with Overall Survival and Postoperative Complications, run by Ruijin Hospital.
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 7 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Minhua Zheng, PhD (+86-13564119545, zmhtiger@yeah.net), 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: 3 years). 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 NCT02942238, which also lists 9 linked publications.
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 21 Dec 2016.