Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

February 16, 2022

Primary Completion Date

May 8, 2024

Study Completion Date

May 8, 2024

Conditions
Locally Advanced Pancreatic CancerMetastatic Pancreatic Cancer
Interventions
DRUG

Neulapeg

Participants will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (Must be administered within a maximum of 72 hours; Neulapeg will only be given for up to 8 cycles).

OTHER

Control

Patients assigned to the non-Neulapeg arm will be crossover to Neulapeg if they develop grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of Neulapeg as a secondary treatment regardless of starting cycle.

Trial Locations (1)

Unknown

Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER