Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness

NCT ID: NCT05881746

Last Updated: 2023-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2028-07-01

Brief Summary

In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.

Detailed Description

This study is a prospective, single-center, randomized control trial. The major including criteria are (1) Histologically confirmed colorectal cancer initially resectable liver-only metastases ; (2) patient has the opportunity to perform either anatomical resection (AR) or nonanatomical resection (NAR) surgery; (3) the number of metastasis is 1-3; (4) KRAS/NRAS/BRAF mutation or right-sidedness. Patients will be randomised between AR or NAR. Patients will be stratified for gene mutation and right-sidedness.

Based upon the segmental anatomy of the liver according to Couinaud system, AR is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof. NAR, also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

The primary end-point is the relapse-free survival. The secondary end-points are postoperative complication, postoperative mortality, hospital length of stay, and overall survival.

Conditions

Colorectal Carcinoma; Liver Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

anatomical resection group

Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof.

Group Type: EXPERIMENTAL

anatomical liver resection

Intervention Type: PROCEDURE

Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these.

nonanatomical resection group

nonanatomical resection (NAR), also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

Group Type: ACTIVE_COMPARATOR

nonanatomical liver resection

Intervention Type: PROCEDURE

Nonanatomical resection(NAR), known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.

Interventions

anatomical liver resection

Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) was defined as resection of 1 or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination of these.

Intervention Type: PROCEDURE

nonanatomical liver resection

Nonanatomical resection(NAR), known as wedge resection, was defined as resection of the tumor with a margin of normal parenchyma without regard to hepatic anatomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;

2. Histological proof of colorectal adenocarcinoma;

3. Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);

4. Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);

5. Number of metastasis is 1 to 3;

6. KRAS/NRAS/BRAF mutation or right-sidedness;

7. Performance Status (ECOG) 0~1;

8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);

9. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;

10. Written informed consent.

Exclusion Criteria

1. Previous systemic treatment for metastatic disease;

2. Previous surgery for metastatic disease;

3. Extrahepatic metastases;

4. Unresectable primary tumor;

5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;

6. Second primary malignancy within the past 5 years;

7. Acute or subacute intestinal obstruction;

8. Drug or alcohol abuse;

9. No legal capacity or limited legal capacity;

10. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xu jianmin

Director of the Department of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianmin Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jianmin Xu, MD

Role: CONTACT

xujmin@aliyun.com

86-18917982975

Yijiao Chen, MD

Role: CONTACT

13636443958@163.com

86-13636443958

Other Identifiers

ARCLAMP

Identifier Type: -

Identifier Source: org_study_id