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

NCT05881746 | Not Yet Recruiting

• 1 other identifier: ARCLAMP
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• overall survival

  5 years

• postoperative hospital stay

  30 days post operatively

• postoperative complication

  After surgery during one month

• postoperative mortality

  After surgery during 90 days

Study Arms (2)

anatomical resection group

EXPERIMENTAL

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.

Procedure: anatomical liver resection

nonanatomical resection group

ACTIVE COMPARATOR

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.

Procedure: nonanatomical liver resection

Interventions

anatomical liver resection 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.

anatomical resection group

nonanatomical liver resection 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.

nonanatomical resection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 75 years;
• Histological proof of colorectal adenocarcinoma;
• Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);
• Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);
• Number of metastasis is 1 to 3;
• KRAS/NRAS/BRAF mutation or right-sidedness;
• Performance Status (ECOG) 0\~1;
• Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);
• 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;
• Written informed consent.

You may not qualify if:

• Previous systemic treatment for metastatic disease;
• Previous surgery for metastatic disease;
• Extrahepatic metastases;
• Unresectable primary tumor;
• Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
• Second primary malignancy within the past 5 years;
• Acute or subacute intestinal obstruction;
• Drug or alcohol abuse;
• No legal capacity or limited legal capacity;
• Pregnant or lactating women.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jianmin Xu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianmin Xu, MD

CONTACT

86-18917982975; xujmin@aliyun.com

Yijiao Chen, MD

CONTACT

86-13636443958; 13636443958@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Colorectal Surgery

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)