NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000486

Registered date:12/09/2006

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedLocally advanced pancreatic cancer
Date of first enrollment2006/07/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeSurvival and adverse events
Secondary OutcomeProgression free survival, response rate, and CA19-9 response.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1)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

Contact

public contact
Name Masafumi Ikeda, MD.
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan
Telephone 03-3542-2511
E-mail masikeda@ncc.co.jp
Affiliation S-1 Radiation Coordinating Office Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
scientific contact
Name Takuji Okusaka, MD, PhD
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan Japan
Telephone 03-3542-2511
E-mail
Affiliation National Cancer Center Hospital Hepatobiliary and Pancreatic Oncology Division