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Investigate the Radical Extent of Lymphadenectomy of LAparoscopic Right Colectomy for Colon Cancer(RELARC). (RELARC)

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ClinicalTrials.gov Identifier: NCT02619942
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
Chinese PLA General Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Beijing Cancer Hospital
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Ruijin Hospital
Shanghai Zhongshan Hospital
First Hospital of Jilin University
Nanfang Hospital of 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
Information provided by (Responsible Party):
XIAO Yi, MD, Peking Union Medical College Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: D2 radical operation Procedure: Complete mesocolic excision (CME) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1072 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 30 days ]
  2. Postoperative mortality [ Time Frame: 30 days ]
  3. 3 years overall survival [ Time Frame: 3 years ]
  4. Metastasis rate of central lymph node (3rd station) [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients suitable for curative surgery 18-75years old
  2. ASA grade I-III
  3. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
  4. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
  5. Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T2-T4N0 or TanyN+; there is no distant metastasis.
  6. Informed consent

Exclusion Criteria:

  1. Simultaneous or simultaneous multiple primary colorectal cancer;
  2. 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;
  3. 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;
  4. 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;
  5. Patients need emergency operation;
  6. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
  7. Informed consent refusal
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lai XU, MD +861015810470115 xulaipumch@163.com
Contact: Jun-yang LU, MD lujunyang@pumch.cn

Locations
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China, Beijing
Lai XU Recruiting
Beijing, Beijing, China, 100730
Contact: Lai XU, MD    +861015810470115    xulaipumch@163.com   
Principal Investigator: Yi XIAO, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Chinese PLA General Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Beijing Cancer Hospital
Beijing Friendship Hospital
Xuanwu Hospital, Beijing
Ruijin Hospital
Shanghai Zhongshan Hospital
First Hospital of Jilin University
Nanfang Hospital of 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
Investigators
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Principal Investigator: Yi XIAO, MD Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: XIAO Yi, MD, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02619942     History of Changes
Other Study ID Numbers: RELARC
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by XIAO Yi, MD, Peking Union Medical College Hospital:
Right colon cancer, Survival, Laparoscopic surgery
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases