EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden

Launched by OSLO UNIVERSITY HOSPITAL · Apr 8, 2021

Keywords

ClinConnect Summary

This clinical trial, called the EXtended CriteriA Treatment for Liver Metastases and Heavy Tumour BURden, is studying the best treatment options for patients with colorectal cancer that has spread to the liver. Specifically, it aims to compare the outcomes of surgery (resection) with continued chemotherapy in patients who have multiple liver metastases and have not responded well enough to their initial chemotherapy treatment. By doing this, researchers hope to find out if surgery offers any real benefits for these patients or if they would do just as well with more chemotherapy alone.

To participate in this trial, patients must be adults aged 65 to 74 who have a confirmed diagnosis of colorectal cancer with liver metastases that can be surgically removed. They should have had at least one round of chemotherapy that didn’t work well and meet certain criteria regarding the number and size of their liver metastases. Participants will be randomly assigned to either receive surgery or continue with chemotherapy, and researchers will monitor their progress. If you or a loved one is considering joining this trial, it’s important to discuss it with your healthcare provider to understand if it’s the right choice.

Gender

ALL

Eligibility criteria

• 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.
• • -