NCT05881746Not yet recruiting
Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness
Anatomical Resection Versus Nonanatomical Resection for Colorectal Liver Metastases Patients With Gene Mutation or Right-sidedness: The ARCLAMP Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 31 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 176 (estimated)
- First submitted
- 15 May 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Fudan University
- Diseases
- Colorectal cancer
- NCT number
- NCT05881746
What you commit to
- Study type: Interventional
- Planned participants: 176
- From 1 Jul 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic treatment for metastatic disease;
- Previous surgery for metastatic disease;
- Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
- Drug or alcohol abuse;
Other illness
- Second primary malignancy within the past 5 years;
Other
- Extrahepatic metastases;
- Unresectable primary tumor;
- Acute or subacute intestinal obstruction;
- No legal capacity or limited legal capacity;
- Pregnant or lactating women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.