Phase Ib-II, non-randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with modFOLFIRINOX for front-line treatment of metastatic pancreatic adenocarcinoma

Conditions

Histologically confirmed pancreatic adenocarcinoma with liver metastases, with no previous systemic treatment in the metastatic setting

Brief summary

Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX, measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0.

Detailed description

Total hours with TTField device functioning during every 14 days chemotherapy cycle, QoL assessed using EORTC QLQ-30 questioner, Progression-free survival (PFS): defined as the time from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first, Overall survival (OS): defined as the time from first modFOLFIRINOX administration until patient death, Overall response rate (ORR): defined as the percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1, Disease control rate (DCR): defined as the percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1

Related papers

No related papers found yet.

Interventions

DRUGOXALIPLATIN

DRUGCALCIUM FOLINATE

DRUGFLUOROURACIL

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Toxicity profile in patients with mPDAC treated at 1L with TTFields concomitantly with modFOLFIRINOX, measured by the rate of patients with treatment-emergent adverse events (TEAEs), using CTCAE v5.0.	—

Secondary

Measure	Time frame
Total hours with TTField device functioning during every 14 days chemotherapy cycle, QoL assessed using EORTC QLQ-30 questioner, Progression-free survival (PFS): defined as the time from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first, Overall survival (OS): defined as the time from first modFOLFIRINOX administration until patient death, Overall response rate (ORR): defined as the percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1, Disease control rate (DCR): defined as the percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1	—

Measure

Time frame

Total hours with TTField device functioning during every 14 days chemotherapy cycle, QoL assessed using EORTC QLQ-30 questioner, Progression-free survival (PFS): defined as the time from first modFOLFIRINOX administration until disease progression based on CT scan collected on the study according to RECIST 1.1 criteria or any cause related death, whichever occurs first, Overall survival (OS): defined as the time from first modFOLFIRINOX administration until patient death, Overall response rate (ORR): defined as the percentage of patients with complete response (CR) or partial response (PR) as best overall response (BOR) according to RECIST 1.1, Disease control rate (DCR): defined as the percentage of patients with CR or PR and the percentage of subjects with stable (SD) of at least 12 weeks duration as BOR according to RECIST 1.1

—

Countries

Spain

Outcome results

None listed