NIPH Clinical Trials Search

UMIN ID: UMIN000002183

Registered date:10/07/2009

A Phase I/II study of combination of TS-1, CDDP plus PTX in patients with advanced/recurrent gastric cancer (OGSG 0703)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced/recurrent gastric cancer
Date of first enrollment2009/05/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Treatment Methd CDDP 30mg/m2:day 1, day15, PTX 70mg/m2:day 1, day15, TS-1 80/mgm2:day1 – 21(on), day22 – 35(off) A 5 weeks is the one course


Primary OutcomeResponse rate
Secondary Outcomeoverall survival(OS),progression free survival, and Incidence of adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria(1) with bleeding from digestive tract (2) patients who cannot take orally due to some stenosis on digestive tract (3) past history of severe allergy against some medicines (4) with high volume of ascites and/or thoratic fluid (5) with severe diseases (infection, interstitial pneumonitis, pulmonary fibrosis, cardiac failure, renal failure, liver disease, uncontrollable DM) (6) with liver cirrhosis and/or jaundice (7) with psychologic disorder which needs medicines (8) with brain disorder due to brain metastasis (9) with active second cancers. (10) women under pregnancy or women expecting future birth (11) doctors decision not to register to this trial

Related Information


public contact
Name Hiroshi Furukawa
Address 377-2, Onohigashi, Osakasayama, Osaka, Japan Japan
Telephone 072-366-0221
Affiliation Kinki University Faculty of Medicen Department of surgery
scientific contact
Name Kimura Yutaka
Address 543-8922 2-6-40Karasugatuji Tennnouji-Ku Osaka Japan
Telephone 06-6773-7111
Affiliation NTT West Japan Hospital Dpt.Surgery