Status:
SUSPENDED
EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden
Lead Sponsor:
Oslo University Hospital
Conditions:
Liver Metastases
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients with multiple colorectal liver metastases that progress on 1st line chemotherapy have a very dismal prognosis, and their options are few. Resections are regularly performed although this is o...
Detailed Description
Colorectal cancer (CRC) is the second most frequent malignant disease in Norway (Cancer in Norway 2017). About 50% of the patients will have metastatic disease at the time of diagnosis or develop meta...
Eligibility Criteria
Inclusion
- Verified adenocarcinoma in colon or rectum
- Liver metastases that are technically resectable (ablation can be used as an adjunct) without PVE, HVE or ALPPS, but judged in need of further (next line) chemotherapy based on insufficient response to at least one line of chemotherapy. And either
- a. Six or more liver metastases, with extra-hepatic disease i. def: \>3 pulmonary metastases/radiologically positive non-liver hilar lymph nodes. Or b. Ten or more liver metastases with at least one of the following negative prognostic signs: i. At least one lesion \> 7 cm in diameter before chemotherapy ii. CEA \> 100 following a full cycle of chemotherapy)?? iii. KRAS and/or BRAF mutant primary tumour. iv. Node positive primary tumour. Or c. Fifteen or more liver metastases
- ECOG 0/2
- Informed consent
Exclusion
- Any of the following criteria will exclude participation in the trial:
- New liver metastases emerging during completed chemotherapy.
- a. These patients may be included if they undergo a complete cycle of next line chemotherapy without new liver metastases emerging.
- Previous or current bone or CNS metastatic disease
- Any other reason why, in the opinion of the investigators, the patient should not participate.
- \-
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04840186
Start Date
March 23 2021
End Date
March 1 2026
Last Update
November 12 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Oslo County, Norway, 0372