Colon CancerRELARCNCT02619942
Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC).
A study testing D2 radical operation and Complete mesocolic excision (CME) in people with Colon Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- D2 radical operation and Complete mesocolic excision (CME)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2016to 26 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
- ASA grade I-III
- 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 T2-T4N0 or TanyN+; there is no distant metastasis.
- Informed consent
Who cannot join
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed;
- 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, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
- Patients need emergency operation;
- Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.
To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.
Read the detailed description
Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group).
The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended.
The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
- Conditions
- Colon Cancer
- Being tested
- D2 radical operation, Complete mesocolic excision (CME)
- Keywords
- Right colon cancer, Survival, Laparoscopic surgery
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D2 radical operationProcedure or surgery
In D2 radical operation group(D2), 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.
Complete mesocolic excision (CME)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| D2 radical operation group | Active comparator | In D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels. Receives: Procedure: D2 radical operation |
| CME group | Experimental | In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed. Receives: Procedure: Complete mesocolic excision (CME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
Measured: 3 years
Secondary outcomes (4)
Postoperative complications
Complications occurring within 30 days after surgery
Measured: 30 days
Postoperative mortality
Death occurred within 30 days after surgery
Measured: 30 days
3 years overall survival
The proportion of patients who survived 3 years after surgery
Measured: 3 years
Metastasis rate of central lymph node (3rd station)
Metastasis rate of central lymph node (3rd station)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start9 Jan 2016
- Primary completion26 Dec 2019
- Study completion26 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Xuanwu Hospital, Beijing, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking Union Medical College, Peking University People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, RenJi Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital
- Responsible party
- Principal investigator, XIAO Yi, MD, Peking Union Medical College Hospital
- Investigators
- Yi XIAO, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619942
- Sponsor's protocol ID
- RELARC
- Acronym
- RELARC
- Status last verified
- Feb 2020
- First submitted
- 29 Nov 2015
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li K, Li H, Wu A, Zang L, Zhang G, Xu L, Lu J, Xing J, Feng B, Sun Y, Du X, Chi P, Xu J, Wang Z, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC Study Group. Long-Term Survival on Extent of Lymphadenectomy for Right-Sided Colon Cancer: Five-Year Follow-up Results of a Randomized Controlled Trial (RELARC Trial). Ann Surg. 2025 Sep 12. doi: 10.1097/SLA.0000000000006941. Online ahead of print.
PubMed 40938728Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.
PubMed 39190853Sun Z, Zhang G, Lu J, Wu B, Lin G, Xiao Y, Xu L. Risk Factors for Postoperative Complications of Laparoscopic Right Colectomy: A Post Hoc Analysis of the RELARC Trial. Dis Colon Rectum. 2024 Sep 1;67(9):1194-1200. doi: 10.1097/DCR.0000000000003331. Epub 2024 May 21.
PubMed 38773832Xu L, Su X, He Z, Zhang C, Lu J, Zhang G, Sun Y, Du X, Chi P, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Z, Zheng M, Xiao Y; RELARC Study Group. Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial. Lancet Oncol. 2021 Mar;22(3):391-401. doi: 10.1016/S1470-2045(20)30685-9. Epub 2021 Feb 12.
PubMed 33587893Lu JY, Xu L, Xue HD, Zhou WX, Xu T, Qiu HZ, Wu B, Lin GL, Xiao Y. The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial. Trials. 2016 Dec 8;17(1):582. doi: 10.1186/s13063-016-1710-9.
PubMed 27931247
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Clinical Trial to Investigate the Radical Extent of Lymphadenectomy: D2 Dissection vs. Complete Mesocolic Excision, of LAparoscopic Right Colectomy for Right-sided Colon Cancer.
- ClinicalTrials.gov ID
- NCT02619942
- Acronym / sponsor ID
- RELARC / RELARC
- Conditions
- Colon Cancer
- Keywords
- Right colon cancer, Survival, Laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,072 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Xuanwu Hospital, Beijing, Ruijin Hospital, Shanghai Zhongshan Hospital, The First Hospital of Jilin University, Nanfang Hospital, Southern Medical University, Fujian Medical University Union Hospital, Peking Union Medical College, Peking University People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, RenJi Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, West China Hospital
- Study start
- 9 Jan 2016 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 26 Dec 2022 (estimated)
- First posted
- 2 Dec 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.
To investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve disease-free survival in patients with right colon cancer, compared with standard D2 radical operation.
Detailed description
Our study design is a two-arm, parallel-group, single-blind randomized clinical trial. The enrolled colon cancer patients would be divided into the intervention group (CME group) and control group (D2 radical operation group).
The postoperative adjuvant chemotherapy is determined by the pathological results. For patients of stage Ⅲ and patients of stage Ⅱ with unfavorable histologic features, six months of adjuvant chemotherapy of XELOX or fluorouracil-based regimen are recommended.
The postoperative examination should be performed every four months in the first two years and every six months in the following three years, to exclude local recurrence and distant metastasis.
Our study is expected to last five years, of which two years for recruiting patients, three years for follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2 radical operation group | Active comparator | Procedure: D2 radical operationIn D2 radical operation group(D2), the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes, which along the feeding vessels. |
| CME group | Experimental | Procedure: Complete mesocolic excision (CME)In complete mesocolic excision group (CME), in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodesmshould be entirely removed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suitable for curative surgery 18-75years old
- ASA grade I-III
- 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 T2-T4N0 or TanyN+; there is no distant metastasis.
Key exclusion criteria (7 listed)
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show: (1) colon cancer of stage T1N0; (2) enlargement of lymph node at the root of mesocolon, in which case the D3 radical operation must be performed;
- 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, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
- Patients need emergency operation;
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 |
|---|---|---|
| D2 radical operationIn D2 radical operation group(D2), 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. | Procedure or surgery | D2 radical operation group |
| Complete mesocolic excision (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. | Procedure or surgery | CME group |
Primary outcome
Disease-free survival
Time frame: 3 years
The proportion of patients with no disease recurrence and metastasis after 3 years of surgery
4 secondary outcomes
Postoperative complications
Time frame: 30 days
Postoperative mortality
Time frame: 30 days
3 years overall survival
Time frame: 3 years
Metastasis rate of central lymph node (3rd station)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Derived from this study: PubMed 40938728Li K, Li H, Wu A, Zang L, Zhang G, Xu L, Lu J, Xing J, Feng B, Sun Y, Du X, Chi P, Xu J, Wang Z, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC Study Group. Long-Term Survival on Extent of Lymphadenectomy for Right-Sided Colon Cancer: Five-Year Follow-up Results of a Randomized Controlled Trial (RELARC Trial). Ann Surg. 2025 Sep 12. doi: 10.1097/SLA.0000000000006941. Online ahead of print.
- Derived from this study: PubMed 39190853Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.
- Derived from this study: PubMed 38773832Sun Z, Zhang G, Lu J, Wu B, Lin G, Xiao Y, Xu L. Risk Factors for Postoperative Complications of Laparoscopic Right Colectomy: A Post Hoc Analysis of the RELARC Trial. Dis Colon Rectum. 2024 Sep 1;67(9):1194-1200. doi: 10.1097/DCR.0000000000003331. Epub 2024 May 21.
- Derived from this study: PubMed 33587893Xu L, Su X, He Z, Zhang C, Lu J, Zhang G, Sun Y, Du X, Chi P, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Z, Zheng M, Xiao Y; RELARC Study Group. Short-term outcomes of complete mesocolic excision versus D2 dissection in patients undergoing laparoscopic colectomy for right colon cancer (RELARC): a randomised, controlled, phase 3, superiority trial. Lancet Oncol. 2021 Mar;22(3):391-401. doi: 10.1016/S1470-2045(20)30685-9. Epub 2021 Feb 12.
- Derived from this study: PubMed 27931247Lu JY, Xu L, Xue HD, Zhou WX, Xu T, Qiu HZ, Wu B, Lin GL, Xiao Y. The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial. Trials. 2016 Dec 8;17(1):582. doi: 10.1186/s13063-016-1710-9.
- The Radical Extent of lymphadenectomy D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled triaLink provided by the sponsor.
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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.
Yi XIAO, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D2 radical operation and Complete mesocolic excision (CME) in people with Colon Cancer, run by Peking Union Medical College 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 6 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 11 Feb 2020. 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.
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?
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 NCT02619942, which also lists 5 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 11 Feb 2020.