Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network (NCT03164655) | Clinical Trial Compass
CompletedPhase 2
Improving SUrgery of Liver Metastases: a Trial of the Arterial Chemotherapy Network
France20 participantsStarted 2018-07-25
Plain-language summary
National trial, multicenter, randomized, phase II comparing treatment intensification with hepatic arterial infusion chemotherapy plus systemic chemotherapy (CT) to systemic chemotherapy alone in patients with liver-only colorectal metastases (CRLM) considered still non resectable after at least two months of systemic induction chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed colorectal cancer (CRC), and radiologic or histologic proof of CRLM not amenable to a curative intent-treatment.
✓. At least two months of prior induction systemic CT with oxaliplatin and/or irinotecan combined with a fluoropyrimidine combined or not to a targeted therapy (e.g., anti-EGFR or antiangiogenic antibody) for metastatic disease (patients ending their adjuvant chemotherapy after primary tumor resection since more than 6 months should also have received first-line chemotherapy for metastatic disease). Further systemic chemotherapy lines are allowed.
✓. Unresectability of the CRLM will be confirmed by a centralized multidisciplinary expert panel (composed of surgeons, radiologists, interventional radiologists and medical oncologists). The panel will review the CT scan and MRI of the patients (weekly web conference). Non-resectability criteria (one of the following criteria):
✓. At least one measurable liver metastasis according to the RECIST v1.1
✓. Age ≥18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Normal liver function, i.e. bilirubin \<1.5 times the upper limit of normal values (ULN), aminotransferases \<5 ULN, alkaline phosphatase \<5 ULN
✓. International normalized ratio (INR) \<1.5 ULN
Exclusion criteria
✕. Patient eligible for curative-intent treatment of CRLM (i.e. resection and/or thermoablation), according to the local multidisciplinary team and/or the central review.
What they're measuring
1
Curative-intent (R0-R1) resection (and/or ablation) rate (CRR) of CRLM
. Definitive anatomical contraindication to complete surgical resection (any of the following criteria):
✕. Extrahepatic tumor disease (except ≤3 lung nodules \<10 mm deemed amenable to curative-intent resection/thermoablation and non-resected primary tumor with no or mild symptoms)
✕. Patient with contraindication for trial drugs (investigators have to refer to drugs SmPC); contraindication limited to targeted therapy (e.g., anti-EGFR or antiangiogenic antibody) is not an exclusion criteria
✕. Disease progression after FOLFOXIRI/FOLFIRINOX
✕. Sensory neuropathy ≥ grade 2 (National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0)
✕. If patients received bevacizumab, following non-inclusion criteria must be respected:
✕. If patients received panitumumab, following non-inclusion criteria must be respected: