A Phase II trial of S-1 and concurrent radiotherapy for locally advanced pancreatic cancer

UMIN ID: UMIN000000486

Registered date:12/09/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Locally advanced pancreatic cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent radiotherapy with S-1 and maintenance therapy of S-1 was administered until disease progression or unacceptable toxicity. Concurrent radiotherapy with S-1: S-1; 80mg/m2 on the irradiated day. Radiotherapy; a total dose of 50.4 Gy in 28 fractions over 5.5 weeks. Maintenance therapy of S-1: 80mg/m2 for 28 days, followed by a rest period of 14 days.

Outcome(s)

• Primary Outcome: Survival and adverse events
• Secondary Outcome: Progression free survival, response rate, and CA19-9 response.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)Watery diarrhea 2)Use of phenytoin, warfarin potassium, or flucytosine 3)Pleural effusion or ascites 4)Active infection 5)Active concomitant malignancy 6)Active gastroduodenal ulcer 7)Severe complication, such as heart disease, renal disease, and hepatic disease 8)Severe mental disorder 9) Severe allergic reaction to drug 10)Active concomitant malignancy, pregnant and lactating females, and females of childbearing age unless using effective contraception

Related Information

• Primary Sponsor: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
• Source(s) of Monetary Support: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital