NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000037

Registered date:05/08/2005

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedresectable pancreatic cancer
Date of first enrollment2002/04/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)adjuvant systemic chemotherapy with gemcitabine 1000mg/m2 IV on days 1, 8, 15 every 28 days x 3 courses observation

Outcome(s)

Primary Outcomesurvival time, recurrence rate
Secondary Outcomeadverse effect

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteriahistologically 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
Exclude criteriainterstitial 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

Related Information

Contact

public contact
Name Tomoo Kosuge
Address Japan
Telephone 03-3542-2511
E-mail
Affiliation Office of the Study Group for Adjuvant Chemotherapy of Pancreatic Cancer National Cancer Center Hospital, HBP Surgery Division
scientific contact
Name Tomoo Kosuge
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan
Telephone 03-3542-2511
E-mail
Affiliation National Cancer Center Hospital HBP Surgery Division