Clinical trial · Interventional
EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden
NCT04840186CI-TRIAL-00082472EXCALIBUR3suspendedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough patients
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2nd line chemotherapy | Drug | — | UNRESOLVED |
| Liver-resection or ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 2nd line chhemotherapy
- description
- Patients in this arm will be receiving the standard care which is 2nd line chemotherapy. Type of chemotherapy determined by treating oncologist.
- interventionNames
- Drug: 2nd line chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- 2nd line chemotherapy + resection
- description
- Patients in this arm will be treated with liver resection and/or ablation at Oslo University Hospital followed by adjuvant 2nd line chemotherapy. Type of chemotherapy is determined by treating oncologist.
- interventionNames
- Procedure: Liver-resection or ablation
- Drug: 2nd line chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Verified adenocarcinoma in colon or rectum 2. 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 3. ECOG 0/2 4. Informed consent Exclusion Criteria: Any of the following criteria will exclude participation in the trial: 1. 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. 2. Previous or current bone or CNS metastatic disease 3. Any other reason why, in the opinion of the investigators, the patient should not participate. \-
References
Publications (0)
Data not yet available
No reference posted for this study.