A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer

A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer - A feasibility study of the use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy for unresectable pancreatic cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016595

Enrollment

Registered

2015-02-21

Start date

2015-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unresectable pancreatic cancer

Interventions

The use of peg-filgrastim as primary prophyraxis for FOLFIRINOX therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria were: unresectable pancreatic cancer (locally advanced or metasitatic); an Eastern Cooperative Oncology Group PS of 0 or 1; adequate organ fuction (neutrophil count>2000/mm3, platelet count>10,000/mm3, total bilirubin <upper limit of normal*1.5); with written informed concent

Exclusion criteria

Exclusion criteria: Patients are excluded if they have received prior chemotherapy or radiation therapy ( except for adjuvant chemotherapy); UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UTG1A1*6 and UGT1A1*28; diarrrhea including water stools; active infection or other serious concomitant diseases.

Design outcomes

Primary

Measure	Time frame
relative dose indensity	—

Secondary

Measure	Time frame
neutropenia, febrile neutropenia, other adverse events(anemia, thrombocytopenia, anorexia, nausea, vommiting, diarrhea, peripheral sensory neuropathy), treatment cycles	—

Countries

Japan

Contacts

Public ContactAyumu Matsuoka

Nagoya University Hospital Department of Clinical Oncology and Chemotherapy

ayumu0611@med.nagoya-u.ac.jp052-744-1903

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026