Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT)
Netherlands31 participantsStarted 2020-09-09
Plain-language summary
The PUMP-IT study is designed to prove the feasibility of HAIP chemotherapy with concomitant standard systemic chemotherapy (FOLFOX and FOLFIRI) in the Netherlands. This study will include patients with both unresectable CRLM and resectable CRLM with an indication for upfront systemic therapy (further referred to as potentially resectable CRLM), without extrahepatic metastases. The study will be performed in two tertiary referral centers in the Netherlands.
Who can participate
Age range18 Years – 115 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years.
* ECOG performance status 0 or 1.
* Life expectancy of at least 12 weeks.
* Histologically confirmed CRC.
* Indication for first or second line systemic therapy, confirmed in a multidisciplinary meeting.
* Potentially resectable (i.e. unresectable and upfront resectable CRLM with indication for neoadjuvant systemic therapy), confirmed in a multidisciplinary meeting and radio-logically on (PET) CT thorax/abdomen and/or MRI obtained ≤ 4 weeks prior to regis-tration.
* Positioning of a catheter for HAIP chemotherapy is technically feasible confirmed in the multidisciplinary liver meeting based on imaging. The default site for the catheter insertion is the gastroduodenal artery (GDA). Accessory or aberrant hepatic arteries are no contra-indication for catheter implantation. The GDA should have at least one branch to the liver, accessory or aberrant hepatic arteries should be ligated to allow for cross perfusion to the entire liver through intrahepatic shunts.
* Indication and eligibility for abdominal surgery confirmed in a multidisciplinary meeting, e.g. primary tumour resection, stoma revision/reversal and diagnostic surgery.
* In case of primary tumour in situ: tumour should be (potentially) resectable, confirmed in a multidisciplinary meeting.
* Adequate bone marrow, liver and renal function as assessed by the following labora-tory requirements to be conducted within 15 days prior to inclusion.
* Hb ≥ 5.5 mmol/L
* Absolute neutrophi…
What they're measuring
1
Completion of 2 combined chemotherapy cycles (feasibility)
Timeframe: Approximately 4 months after patient inclusion