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PUMP-IT RCT

Acronym

PUMP-IT RCT

Name of the study

Hepatic arterial infusion PUMP chemotherapy combined with systemic therapy versus systemic therapy alone as Induction Therapy for initially unresectable colorectal liver metastases: a randomised controlled trial

Researchers and contact information

PI - Koert Kuhlmann, k.kuhlmann@nki.nl

Trial coordinator – Elisa ter Kuile, pump@nki.nl

Address - Netherlands Cancer institute, Surgical Oncology (U2), Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands

Website:

 Darmkanker met niet-operabele uitzaaiingen lever: PUMP-IT studie | AVL

 

Documents:

On request, mail: pump@nki.nl

Summary study

Rationale – In patients with colorectal cancer metastases confined to the liver (CRLM), local treatment (i.e. surgery, ablation or radiotherapy) liver metastases may offer a chance of cure or long-term survival. The vast majority of these patients however presents with unresectable disease. Current induction treatment of unresectable CRLM includes subsequent lines of systemic (chemo) therapy aiming to convert the CRLM from unresectable to resectable or amenable for local treatment.

With hepatic arterial infusion pump (HAIP) therapy, the pump is surgically implanted and delivers chemotherapy continuously and directly to the liver via the hepatic artery. Blood supply of CRLM is mainly arterial. Floxuridine (FUDR) is the chemotherapeutic agent used in HAIP therapy. FUDR has a high first-pass liver extraction rate of 95% which results in limited systemic side effects and enables a 400-fold higher concentration in the tumor cells compared to systemic administration. HAIP-therapy has been used for many years in Memorial Sloan Kettering Cancer Center (MSKCC) in New York (USA) with promising results. This phase III trial is preceded by a safety feasibility study: the PUMP-IT pilot.  

Objective – the primary endpoint is to investigate whether HAIP-SYST prolongs survival in chemo-naive patients with initially unresectable colorectal liver metastases as compared with systemic therapy alone.

Study design - Multicenter, open label, randomized controlled trial

Study population – Chemotherapy-naive patients with synchronous initially unresectable colorectal liver metastases (CRLM) without extrahepatic disease.

Main study parameters/endpoints: The primary endpoint is overall survival. Secondary endpoints are progression free survival, liver-specific progression free survival, conversion to local treatment, radiological response, pathological response, complications, toxicity, quality of life and cost-effectiveness.

 

Intervention

Patients randomized to the intervention arm will undergo surgery for pump implantation and resection of the primary tumor, followed by combined induction treatment: HAIP-therapy (Floxuridine) and systemic therapy (FOLFOX/FOLFIRI).

Patients randomized to the control arm receive systemic therapy according current clinical practice.

Participating centers

Open for inclusion:

  • Antoni van Leeuwenhoek, Amsterdam

Opening soon:

  • Albert Schweitzer Ziekenhuis, Dordrecht
  • Amphia, Breda
  • Amsterdam UMC, Amsterdam
  • Deventer Ziekenhuis, Deventer
  • Erasmus MC, Rotterdam
  • IJsselland Ziekenhuis, Capelle aan den IJssel
  • Isala, Zwolle
  • Jeroen Bosch Ziekenhuis, 's-Hertogenbosch
  • Leids Universitair Medisch Centrum (LUMC), Leiden
  • Maastricht UMC+ (MUMC+), Maastricht
  • Máxima Medisch Centrum (MMC), Eindhoven
  • Medisch Centrum Leeuwarden (MCL), Leeuwarden
  • Medisch Spectrum Twente (MST), Enschede
  • Meander Medisch Centrum, Amersfoort
  • OLVG, Amsterdam
  • Radboud UMC, Nijmegen
  • Spaarne Gasthuis, Hoofddorp
  • Universitair Medisch Centrum Groningen (UMCG), Groningen
  • Universitair Medisch Centrum Utrecht (UMCU), Utrecht

Documents

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