PUMP-IT RCT: 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

Conditions

Colorectal liver metastases

Brief summary

Overall Survival (OS)

Detailed description

Progression-free Survival (PFS), Hepatic Progression-free Survival (hPFS), Conversion to resection rate, Objective response rate (ORR), Disease Control Rate (DCR), Pathological response rate, Surgical complication rate (Clavien Dindo classification), Adverse events and toxicity ≥ 3 (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0), Quality of Life (QoL), Costs per quality adjusted life years (QALYs)

Myrtle F. Krul, Niels F. M. Kok, Harun Osmani, Florian E. Buisman, Bas Groot Koerkamp et al. (21 authors)

British journal of surgery2024-04-014 citations

10.1093/bjs/znae089

Interventions

DRUGIRINOTECAN

DRUGHEPARIN

DRUGOXALIPLATIN

DRUGCAPECITABINE

DRUGBEVACIZUMAB

DRUGFLUOROURACIL

DRUGCALCIUM FOLINATE

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS)	—

Secondary

Measure	Time frame
Progression-free Survival (PFS), Hepatic Progression-free Survival (hPFS), Conversion to resection rate, Objective response rate (ORR), Disease Control Rate (DCR), Pathological response rate, Surgical complication rate (Clavien Dindo classification), Adverse events and toxicity ≥ 3 (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0), Quality of Life (QoL), Costs per quality adjusted life years (QALYs)	—

Measure

Time frame

Progression-free Survival (PFS), Hepatic Progression-free Survival (hPFS), Conversion to resection rate, Objective response rate (ORR), Disease Control Rate (DCR), Pathological response rate, Surgical complication rate (Clavien Dindo classification), Adverse events and toxicity ≥ 3 (according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0), Quality of Life (QoL), Costs per quality adjusted life years (QALYs)

—

Countries

Netherlands

Outcome results

None listed