NCT04840186SuspendedPhase 2
EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Reason given: Not enough patients
Brief summary (registry, in English)
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 only supported by anecdotal evidence for this patient group. We want to assess whether resections actually confer benefit as compared to 2nd line chemotherapy alone, in a randomized controlled trial.
- Status (registry)
- Suspended
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 25 Mar 2021
- Start date
- 23 Mar 2021
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Oslo University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT04840186
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- New liver metastases emerging during completed chemotherapy.
- 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
Other
- Any of the following criteria will exclude participation in the trial:
- Any other reason why, in the opinion of the investigators, the patient should not participate.
- -
Who the study is looking for
- 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
- 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
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Oslo University Hospital | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.