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

UMIN ID: UMIN000000655

Registered date:01/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Resected pancreatic cancer
• Date of first enrollment: 2007/04/01
• Target sample size: 360
• Countries of recruitment: Japan
• Study type: Interventional

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 Outcome: Overall survival
• Secondary Outcome: Incidence of adverse events Relapse-free survival Health-related quality of life

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion 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

• Primary Sponsor: Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
• Source(s) of Monetary Support: Pharma Valley Center, Shizuoka Organization for Creation Industries