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A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of gemcitabine after resection of pancreatic cancer

A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial infusion chemotherapy of 5-fluorouracil plus systemic chemotherapy of gemcitabine after resection of pancreatic cancer - A phase II study to evaluate the effect of adjuvant chemotherapy using hepatic arterial 5FU plus systemic gemcitabine after resection of pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000549
Enrollment
25
Registered
2006-12-15
Start date
2006-12-01
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

resectable pancreatic cancer

Interventions

adjuvant chemotherapy using hepatic arterial 5FU (1000mg/m2) plus systemic gemcitabine (1000mg/m2) on days 1, 8, 15 every 28 days x 6 courses

Sponsors

Nara Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) histologically proven ductal pancreatic cancer 2) no previous treatment 3) older than 20 4) Karnofsky Performance Status >= 50 5) normally functioning other organs 6) patient informed consent by documentation

Exclusion criteria

Exclusion criteria: 1) interstitial pneumonia, pulmonary fibrosis 2) intractable pleural effusion 3) intractable diabetes mellitus or liver dysfunction 4) distant metastasis 5) other active cancers 6) apparent infection 7) sever postoperative complications 8) active peptic ulcer 9) episode of myocardial infarction within three months 10) mental disorders 11) pregnacy or patient's hope to be pregnant

Design outcomes

Primary

MeasureTime frame
disease-free survival time

Secondary

MeasureTime frame
adverse effect, treatment compliance, survival time

Countries

Japan

Outcome results

None listed

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