NIPH Clinical Trials Search

UMIN ID: C000000282

Registered date:14/11/2005

Phase I/II Study of Combination Therapy of Oral Fluorinated Pyrimidine Compound S-1 with Low-dose Cisplatin in Patients with Unresectable and/or Recurrent Advanced Gastric Cancer Step 2: low dose cisplatin given twice a week + S-1

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedunresectable or recurrent gastric cancer
Date of first enrollment2003/12/01
Target sample size52
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)S-1 is administered orally at the dose of 40mg/m2 twice a day for 28 days, followed by 14 days rest. Cisplatin is administered intravenously twice a week for 4 weeks, followed by 2 weeks rest. The doses of cisplatin 1)7.5mg/m2/day x 2/week 2)10mg/m2/day x 2/week 3)15mg/m2/day x 2/week


Primary Outcomeadverse events, anti-tumor effect
Secondary Outcomepharmacokinetics of cisplatin, overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1) Histologically or cytologically demonstrated unresectable or recurrent gastric cancer 2) With measurable or assessable legion(s) 3) Without prior anti-tumor therapy. Hormone therapy and/or immunotherapy within two weeks prior to enrollment are eligible. Postoperative adjuvant therapy not containing CDDP within one month prior to enrollment is eligible. 4) Adequate bone marrow, hepatic and renal function (1)Hb >= 9.0 g/dl (2)WBC 4,000 - 12,000/mm3 (3)neutrophils >= 2,000/mm3 (4)platelets >= 100,000/ mm3 (5)T-Bil <= 1.5mg/dl (6)GOT, GPT <= 2.5 times of normal upper limits (7)Al-p <= 2 times of normal upper limits (8)BUN <= normal upper limits (9)Cr<= normal upper limits (10)CCr >= 50ml/min 5) ECOG performance status (PS) 0 to 1 6) Life expectancy longer than 3 months 7) Oral intake is possible 8) Written informed consent
Exclude criteria1) severe complication(s) 2) symptomatic brain metastases 3) active double cancers 4) women who are currently pregnant, nursing, or plan to become pregnant 5) cases where the investigator disapproved of participation

Related Information


public contact
Name Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Kosei Hirakawa
Address 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan Japan
Telephone 06-6645-3838
Affiliation Osaka City University Graduate School of Medicine Department of Surgical Oncology