A phase 3 study of gemcitabine and S-1 compared with gemcitabine monotherapy in patients with unresectable advanced pancreatic cancer.

UMIN ID: UMIN000002244

Registered date:24/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 2007/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 60mg/m2/day is administered orally twice daily from the evening of day 1 to the morning of day 15 followed by a one week rest. Gemcitabine 1000mg/m2 was administered in a 30-min intravenous infusion on days 8 and 15 of each cycle. The cycle was repeated every 21 days until disease progression.
Gemcitabine 1000mg/m2 was administered in a 30min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until disease progression.

Outcome(s)

• Primary Outcome: progression free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: (1)severe concurrent disease, (2)interstitial pneumonia, (3)massive abdominal or pleural effision (4)mental disoeder, (5)active concomitant malignancy, (6)severe diarrhea, (7)brain metastasis, (8)severe drug hypersensitibity, (9)pregnant or lactating females, (10)regular use of phenytoin, warfarin or frucitocin, (11)inappropriate for entry onto the study, as diagnosed by primary physician.

Related Information

• Primary Sponsor: Chiba Cancer Center
• Source(s) of Monetary Support: None