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A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

ABSTRACT: Interventions: Patients undergo implantation of hepatic arterial catheter and port system percutaneously, and then, receive hepatic arterial administration of 5-fluorouracil at day 1,8, and 15 followed by intravenous administration of irinotecan hydrochloride at day 1 and 15. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Primary outcome(s): Adverse events Study Design: Single arm Non-randomized

DISEASE(S): Metastatic Colorectal Cancer Isolated In The Liver

PROVIDER: 2609482 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The treatment proposed in this clinical investigation plan is to repeatedly administer intra-arterial chemotherapy to hepatic metastases from colorectal cancer when the blood flow to and from the liver has been isolated via balloon catheters. The objective of this study is to evaluate the tumour response, progression-free survival, morbidity and mortality of repeated and isolated intra-arterial hepatic infusion of oxaliplatin compared with the standard systemic chemotherapy (intravenous 5-FU + leucovorin + oxaliplatin [FOLFOX] or oral capecitabine with IV oxaliplatin [XELOX]). The treatment proposed in this study is based on the hypothesis that direct arterial infusion of chemotherapy to metastatic tumours of the liver whilst the blood flow to the organ is isolated could potentially yield benefits that cannot be achieved with existing treatment regimens. There are three treatment stages; implantation of a vascular access device (known as the AVAS), intra-arterial chemotherapy infusions, and explantation of the AVAS. Implantation: the participant is admitted to hospital and the AVAS is surgically implanted under general anaesthetic. The AVAS is an implantable large bore cannula with one end that can be anastomosed directly onto a peripheral vessel and the opposite end exiting the patient’s skin. The device can be opened to access the patient’s vasculature when required and closed when the device is not in use. In accordance with the manufacturer’s Instructions-For-Use (IFU), the AVAS will be implanted in the axillary artery (i.e. the upper pectoral area) or in the common femoral artery (upper thigh) by a trained vascular surgeon. The implantation procedure takes around 2 hours. After implantation, the participant is monitored overnight. Intra- Primary outcome(s): Response rate of tumours in liver as assessed via CT scans (RECIST criteria)[4 weeks after explantation of the AVAS] Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

Dataset Information

A phase I/II study of hepatic arterial 5-flurouracil (5FU) combined with intravenous irinotecan hydrochloride (CPT-11) for metastatic colorectal cancer isolated in the liver. (JCOG 0208-DI)

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