Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer

Pilot study of FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer - FOLFOX/FOLFIRI for locally advanced and metastatic pancreatic cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014079

Enrollment

100

Registered

2014-05-27

Start date

2014-05-30

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

locally advanced and metastatic pancreatic cancer

Interventions

FOLFIRI therapy (1cycle/2week) LV

200mg/m2 div day1, CPT-11

150mg/m2 div day1, 5-FU bolus

400mg/m2 div day1, 5-FU 46h infusion

2400mg/m2 div day1 46h FOLFOX therapy (1cycle/2week) LV

200mg/m2 div day1, L-OHP

85mg/m2 div day1, 5-FU bolus

2400mg/m2 div day1 46h

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histology from pancreatic mass and image diagnosis are suitable for adenocarcinoma. 2) unresectable locally advanced or metastatic pancreatic cancer (a definition; NCCN guide line Version 1.2014) 3) Age upper 20 4) PS(ECOG) between 0 and 2 5) No previous radiation, hormone or chemotherapy for pancreatic cancer (except for adjuvant chemotherapy) 6) with a good condition of important organs within 14 days of registration 7) expected more than 90 days survival 8) written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: 1) with pulmonary fibrosis or interstitial pneumonia which can be detected from X-ray incontrovertibly or has clinical symptom 2) with severe diarrhea within 3 days before entry 3) with other severe diseases (heart failure, renal disfunction, liver disfunction, intestinal paralysis, ileus, uncontrolled DM) 4) patients whom administered Flucitosine or Fenitoin or Warfarin 5) with active double cancers whose disease free period is shorter than 5 years, Carcinoma in situ can be excluded. 6) with infectious disease which needs therapy 7) with body temperature over 38 degrees Celsius 8) women who are pregnant or expect to be pregnant, or nursing female 9) patients whom doctor in chief decides not to register to this study due to psychological disease or symptoms 10) general administration of steroids 11) with indication of FOLFIRINOX therapy 12) in the case of receiving adjuvant chemotherapy, recurrence within 180 days from the last administration of adjuvant chemotherapy

Design outcomes

Primary

Measure	Time frame
Overall survival (OS)	—

Secondary

Measure	Time frame
Progression free survival (PFS), Response Rate (RR), Incidence of grade 3/4 adverse events	—

Countries

Japan

Contacts

Public ContactMasahiro Goto

Osaka Medical College Hospital Cancer Chemotherapy Center

in2030@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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