Randomized phase II study comparing 2nd line therapy for gemcitabine-refractry advanced pancreatic cancer.

UMIN ID: UMIN000002154

Registered date:02/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with gemcitabine-refractry advanced pancreatic cancer.
• Date of first enrollment: 2005/11/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A : Gemcitabine 1,000mg/m2 is administered with for 30-min intravenous infusion on day 1, 8 and 15 every 4 weeks.
Group B : Best available fluoropyrimidine therapy : Each institute can choose following available treatment therapy. 1) UFT therapy : UFT 400 mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks. 2) 5-FU therapy : 5-FU 600mg/m2 is administered with 60-min intravenous infusion on day 1, 8 and 15 every 4 weeks. 3) TS-1 therapy : TS-1 80 mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.

Outcome(s)

• Primary Outcome: Median Survival Time of 2nd line therapy
• Secondary Outcome: Clinical Benefit Response (CBR) Safety Time To Progression (TTP) Overall Survival (OS)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) Lung fibrosis or intestinal pneumoni, and anamnesis or imaging findings. 2) Severe infection. 3) Severe complication. (heart failure, angina pectoris, arrhythmia, diabetes , intestines paralysis, ileus, myocardial infarction within 6 months after the onset.) 4) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy. 5) Watery diarrhea. 6) Jaundice. 7) Uncontrolled pleural or abdominal effusion. 8) Severe drug hypersensitivity. 9) History of other active malignancy. 10) Severe mental illness 11) Patients who are judged inappropriate for the entry into the study by the investigater.

Related Information

• Primary Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology Pancreatic cancer study Group
• Source(s) of Monetary Support: Osaka foundation for the prevention of cancer and cardiovascular diseases