Multi-center randomized controlled trial of gemcitabine in combination with S-1 compared with gemcitabine alone in patients with advanced nonresectable pancreatic cancer

UMIN ID: UMIN000000498

Registered date:05/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced nonresectable pancreatic cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 106
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 40mg/m2 is administered orally twice daily from day 1 to day 14 followed by a two-week rest. Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1 and 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
Gemcitabine 1,000mg/m2 was administered as a 30-min intravenous infusion on day 1, 8, 15. The cycle was repeated every 4 weeks until evidence of disease progression, patient refusal, or unacceptable toxicity.

Outcome(s)

• Primary Outcome: Progression-free Survival Overall Survival Response Rate
• Secondary Outcome: Clinical Benefit Response Tumor Marker Adverse effects

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The exclusion criteria are as follows: active infection, digestive ulcer or bleeding, stomach or esophageal varices, pregnant or lactating women, women of childbearging age, active concomitant malignancy, severe drug hypersensitivity, and the patient inappropriate for entry onto this study in the judgment of the investigator.

Related Information

• Primary Sponsor: Faculty of Medicine, University of Tokyo
• Source(s) of Monetary Support: None