Randomized phase II study comparing Gemcitabine/TS-1 combination chemoradiotherapy with Gemcitabine/TS-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

UMIN ID: UMIN000001990

Registered date:22/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Unresectable locally advanced pancreatic cancer.
• Date of first enrollment: 2009/04/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A : Gemcitabine 1,000mg/m2 is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. TS-1 60mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks.
Group B : Gemcitabine 600mg/m2 is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. TS-1 60mg/m2/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions. Maintenance TS-1+ Gemcitabine combination chemoradiotherapy was administered.

Outcome(s)

• Primary Outcome: Two year survival rate
• Secondary Outcome: Progression free survival(PFS) Overall Survival(OS) Adverse events Response rate

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) Watery diarrhea 3) Severe infection 4) Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5) Massive pleural or abdominal effusion. 6) Metastasis to central nervous system. 7) Active synchronous or metachronous malignancy other than carcinoma in situ. 8) Regular use of frucitocin, fenitoin or warfarin 9) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 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
• Source(s) of Monetary Support: Osaka foundation for the prevention of cancer and cardiovascular diseases data center
• Secondary ID(s): NCT01430052