Name of the study
Hepatic arterial infusion PUMP chemotherapy combined with systemIc chemoTherapy for potentially resectable colorectal liver metastases. The PUMP-IT study.
Researchers and contact information
PI - Koert Kuhlmann, firstname.lastname@example.org
Trial coordinator - Myrtle Krul, email@example.com
Address - Netherlands Cancer institute, Surgical Oncology (U2), Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
On request, mail: firstname.lastname@example.org.
Rationale - Colorectal cancer patients with unresectable liver-only metastases (CRLM) may be cured with local treatment (i.e. surgery, ablation or radiotherapy) of those CRLM. Unfortunately, many patients with CRLM are (initially) not suitable for local treatment. Current treatment of unresectable CRLM includes subsequent lines of systemic (chemo)therapy aiming to convert the CRLM from an unresectable to a resectable or local treatable state in order to prolong survival.
Local high dose chemotherapy in addition to systemic treatment is expected to improve conversion rates and survival. A hepatic arterial infusion pump (HAIP) can deliver continuous high-dose regional chemotherapy (floxuridine) to the CRLM using their unique arterial blood supply, with minimal systemic exposure (e.g. complications). It is not available in the European Union but has been used for many years in Memorial Sloan Kettering Cancer Center (MSKCC) in New York (USA) with promising results.
Objective - The aim of this study is to prove feasibility of HAIP chemotherapy (floxuridine) in combination with systemic chemotherapy consisting of FOLFOX or FOLFIRI.
Study design - Multicenter, open label, interventional, feasibility study.
Study population – 31 adults with potentially resectable CRLM without extrahepatic metastases with an indication for systemic therapy as induction or neoadjuvant therapy. Patients have an indication for laparotomy.
Main study parameters/endpoints: The primary objective of the study is feasibility of the HAIP chemotherapy and concomitant systemic chemotherapy. We define this combination feasible if at least 70% of the included patients scheduled for surgery can be treated with at least 2 cycles of HAIP chemotherapy combined with systemic chemotherapy.
All patients will have surgical implantation of HAIP followed by administration of intra-arterial floxuridine to the liver with concomitant systemic FOLFOX (5-FU, leucovorin and oxaliplatin) or FOLFIRI (5-FU, leucovorin and irinotecan).
Antoni van Leeuwenhoek, Amsterdam
Erasmus MC, Rotterdam