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

Colon Cancer Clinical Trial

— RELARC  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02619942
• Other study ID #: RELARC
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 9, 2016
• Est. completion date: December 26, 2022

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1072
• Est. completion date: December 26, 2022
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Lai XU	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Beijing Cancer Hospital, Beijing Friendship Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Harbin Medical University, First Hospital of Jilin University, Fujian Medical University Union Hospital, Nanfang Hospital of Southern Medical University, Peking Union Medical College, Peking University People's Hospital, RenJi Hospital, Ruijin Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Zhongshan Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	The proportion of patients with no disease recurrence and metastasis after 3 years of surgery	3 years
Secondary	Postoperative complications	Complications occurring within 30 days after surgery	30 days
Secondary	Postoperative mortality	Death occurred within 30 days after surgery	30 days
Secondary	3 years overall survival	The proportion of patients who survived 3 years after surgery	3 years
Secondary	Metastasis rate of central lymph node (3rd station)	Metastasis rate of central lymph node (3rd station)	7 days

External Links

•   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 tria