Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC). (RELARC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02619942|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Procedure: D2 radical operation Procedure: Complete mesocolic excision (CME)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1072 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||January 2021|
Active Comparator: D2 radical operation group
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.
Procedure: D2 radical operation
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.
Experimental: CME group
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.
Procedure: 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.
- Disease-free survival [ Time Frame: 3 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619942
|Contact: Lai XU, MDemail@example.com|
|Contact: Jun-yang LU, MDfirstname.lastname@example.org|
|Beijing, Beijing, China, 100730|
|Contact: Lai XU, MD +861015810470115 email@example.com|
|Principal Investigator: Yi XIAO, MD|
|Principal Investigator:||Yi XIAO, MD||Peking Union Medical College Hospital|