A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer

A Multicenter Randomized Controlled Trial to Evaluate the Effect of Adjuvant Chemotherapy using Gemcitabine After Resection of Pancreatic Cancer - A Randomized Controlled Trial to Evaluate Adjuvant Gemcitabine therapy for Pancreatic Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000037

Enrollment

100

Registered

2005-08-05

Start date

2002-04-01

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

resectable pancreatic cancer

Interventions

adjuvant systemic chemotherapy with gemcitabine 1000mg/m2 IV on days 1, 8, 15 every 28 days x 3 courses observation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: histologically proven ductal pancreatic cancer surgical resection no previous chemo- or radiotherapy Karnofsky Performance Status >= 50 WBC 4000/mm3 - 12000/mm3 Hb >= 9g/dl total bilirubin <= 3mg/dl AST, ALT < upper limit x 5 normal creatinine level

Exclusion criteria

Exclusion criteria: interstitial pneumonia, pulmonary fibrosis intractable pleural effusion distant metastasis other active cancers apparent infection sever postoperative complications active peptic ulcer episode of myocardial infarction within three months mental disorders pregnacy or patient's hope to be pregnant

Design outcomes

Primary

Measure	Time frame
survival time, recurrence rate	—

Secondary

Measure	Time frame
adverse effect	—

Countries

Japan

Contacts

Public ContactTomoo Kosuge

Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer National Cancer Center Hospital, HBP Surgery Division

03-3542-2511

Outcome results

None listed

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