Hepatic Arterial Infusion Pump Chemotherapy Combined With Systemic Chemotherapy (PUMP-IT) (PUMP-IT)
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|ClinicalTrials.gov Identifier: NCT04552093|
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Floxuridine Device: Tricumed IP2000V infusion pump||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with potentially resectable (i.e. unresectable or upfront resectable with an indication for upfront systemic therapy) will receive hepatic artery infusion pump chemotherapy, consisting of floxuridine (FUDR), combined with standard of care systemic therapy (FOLFOX or FOLFIRI).|
|Masking:||None (Open Label)|
|Official Title:||Hepatic Arterial Infusion PUMP Chemotherapy Combined With systemIc chemoTherapy for Potentially Resectable Colorectal Liver Metastases: The PUMP-IT Study.|
|Actual Study Start Date :||September 9, 2020|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Colorectal liver metastases
Patients with potentially resectable colorectal liver metastases will undergo hepatic artery infusion pump placement. Subsequent hepatic artery infusion of floxuridine via the HAIP as well as standard of care Dutch systemic chemotherapy (FOLFOX or FOLRIRI) will be administered in a combined chemotherapy schedule.
Administration of intra-arterial floxuridine via the HAIP (HAIP chemotherapy) to the liver with concomitant Dutch standard of care systemic FOLFOX (5-FU, leucovorin and oxaliplatin) or FOLFIRI (5-FU, leucovorin and irinotecan).
Other Name: FUDR
Device: Tricumed IP2000V infusion pump
Surgical implantation of hepatic artery infusion pump (HAIP) followed by administration of the combined chemotherapy (HAIP and systemic).
- Completion of 2 combined chemotherapy cycles (feasibility) [ Time Frame: Approximately 4 months after patient inclusion ]The percentage of patients that complete two cycles of combined chemotherapy (HAIP chemotherapy and systemic therapy) after being scheduled for surgical implantation.
- Safety: Postoperative complications [ Time Frame: 90 days after surgery ]Surgical complications will be defined according to Clavien-Dindo surgical complications score. Complications of Clavien-Dindo grade 3 or higher are recorded for the first 90 days after surgery. Postoperative complications include those related to the HAIP implantation. Postoperative mortality is defined as any death during hospitalization or within 90 days from surgery.
- Safety: Drug treatment toxicity [ Time Frame: 1.5 year ]Toxicity grade 3 or higher will be recorded from the time of study inclusion according to the CTCAE criteria.
- Safety: Other adverse events [ Time Frame: 1.5 year ]Treatment related serious adverse events (SAE) and adverse events (AE) of grade 3 or higher will be collected continuously from the time of study inclusion until the end of combined chemotherapy. AE are followed up until the event is either resolved or adequately explained, even after the patient has completed his/her study treatment. Nature and duration of any hospitalization, treatment of any AE, and nature and duration of any outpatient care will be recorded.
- Response rate colorectal liver metastases (CRLM) [ Time Frame: 8 months after patient registration ]Response rates of CRLM will be measured according to RECIST criteria
- Progression free survival (PFS) [ Time Frame: 1.5 year ]PFS will be defined from inclusion date until disease progression.
- Overall survival (OS) [ Time Frame: 1.5 year ]OS will be defined from inclusion date until death.
- Conversion rate colorectal liver metastases (CRLM) [ Time Frame: 8 months after patient inclusion ]Conversion rate is defined as the percentage of patients in whom CRLM convert from an unresectable to a resectable state and undergo surgical treatment with curative intent. Possibility of local treatment is at the discretion of the multidisciplinary liver panel.
- Quality of life assessment [ Time Frame: 8 months after patient inclusion ]The quality of life will be examined with validated questionnaires (EORTC QLQ-C30 & EQ-5D-3L).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552093
|Contact: Myrtle F Krul, MDfirstname.lastname@example.org|
|Contact: Roos Steenhuis, MSc||+31205129111|
|Antoni van Leeuwenhoek (NKI-AVL)||Recruiting|
|Amsterdam, Netherlands, 1066 CX|
|Principal Investigator: Koert FD Kuhlmann, MD, PhD|
|Principal Investigator:||Koert FD Kuhlmann, MD, PhD||Antoni van Leeuwenhoek|