Back to resultsAnatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness
Primary Purpose
Colorectal Carcinoma, Liver Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anatomical liver resection
nonanatomical liver resection
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Zhongshan hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
anatomical resection group
nonanatomical resection group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
postoperative hospital stay
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
postoperative complication
Patients will be evaluated for surgical morbidity during 1 month. Postoperative morbidity will be scored according 'Clavien-Dindo Grade'.
postoperative mortality
any death occured within 90 days after the last resection of primary and metastatic lesions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05881746
Brief Title
Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness
Official Title
Anatomical Resection Versus Nonanatomical Resection for Colorectal Liver Metastases Patients With Gene Mutation or Right-sidedness: The ARCLAMP Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma, Liver Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anatomical resection group
Arm Type
Experimental
Arm Description
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.
Arm Title
nonanatomical resection group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
anatomical liver resection
Intervention Description
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
Intervention Name(s)
nonanatomical liver resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
relapse-free survival
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Description
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.
Time Frame
5 years
Title
postoperative hospital stay
Description
The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.
Time Frame
30 days post operatively
Title
postoperative complication
Description
Patients will be evaluated for surgical morbidity during 1 month. Postoperative morbidity will be scored according 'Clavien-Dindo Grade'.
Time Frame
After surgery during one month
Title
postoperative mortality
Description
any death occured within 90 days after the last resection of primary and metastatic lesions
Time Frame
After surgery during 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmin Xu, MD
Phone
86-18917982975
Email
xujmin@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yijiao Chen, MD
Phone
86-13636443958
Email
13636443958@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Xu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness
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