NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000655

Registered date:01/04/2007

Randomiszd phase III trial of adjuvant chemotherapy with gemcitabine vs. S-1 in patients with resected pancreatic cancer

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedResected pancreatic cancer
Date of first enrollment2007/04/01
Target sample size360
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Gemcitabine 1000 mg/m2 is given by intravenous infusion over 30 minutes on days 1, 8, and 15, followed by a 1-week pause. This cycle is repeated for six months or until recurrent disease is confirmed. S-1 40mg/m2 is given orally twice a day for four weeks, followed by a two-week rest. This course is repeated four times or until recurrent disease is confirmed.

Outcome(s)

Primary OutcomeOverall survival
Secondary OutcomeIncidence of adverse events Relapse-free survival Health-related quality of life

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaExclusion criteria are as folllows: 1) Prior history of gemcitabine therapy or S-1 therapy 2) Recurrent disease on enrollment 3) Massive ascites or pleural effusion 4) Plumonary fibrosis or interstitial pneumonia 5) Severe diarrhea 6) NYHA III or IV cardiac function 7) Myocardial infarction within six months 8) Severe infection 9) Severe diabetes 10) Blood transfusion within two weeks 11) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 12) Severe mental disorder 13) Severe drug allergy 14) Other active malignancy 15) Pregnancy, breast feeding, or women who desire to preserve fecundity 16) Men who desire to have children 17) Regular use of frucitocin, fenitoin or warfarin 18) Inadequate physical condition, as diagnosed by primary physician

Related Information

Contact

public contact
Name Katsuhiko Uesaka
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN Japan
Telephone 055-989-5222
E-mail k.uesaka@scchr.jp
Affiliation Shizuoka Cancer Center Hospital Division of Hepato-Biliary-Pancreatic Surgery
scientific contact
Name Katsuhiko Uesaka
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 JAPAN Japan
Telephone 055-989-5222
E-mail k.uesaka@scchr.jp
Affiliation Shizuoka Cancer Center Hospital Division of Hepato-Biliary-Pancreatic Surgery