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

Liver Metastases Clinical Trial

Official title:

Anatomical Resection Versus Nonanatomical Resection for Colorectal Liver Metastases Patients With Gene Mutation or Right-sidedness: The ARCLAMP Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05881746
• Other study ID #: ARCLAMP
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: May 2023
• Source: Fudan University
• Contact: Jianmin Xu, MD
• Phone: 86-18917982975
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 176
• Est. completion date: July 1, 2028
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relapse-free survival	The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death	3 years
Secondary	overall survival	The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.	5 years
Secondary	postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.	30 days post operatively
Secondary	postoperative complication	Patients will be evaluated for surgical morbidity during 1 month. Postoperative morbidity will be scored according 'Clavien-Dindo Grade'.	After surgery during one month
Secondary	postoperative mortality	any death occured within 90 days after the last resection of primary and metastatic lesions	After surgery during 90 days