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Trial Title:
Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness
NCT ID:
NCT05881746
Condition:
Colorectal Carcinoma
Liver Metastases
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Colorectal Neoplasms
Liver Extracts
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
anatomical liver resection
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.
Arm group label:
anatomical resection group
Intervention type:
Procedure
Intervention name:
nonanatomical liver resection
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.
Arm group label:
nonanatomical resection group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
July 1, 2023
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05881746
