NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001252

Registered date:15/07/2008

Randomized phase III study of CPT-11 versus Weekly Paclitaxel for unresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedunresectable or recurrent gastric cancer refractory to combination chemotherapy with fluoropyrimidine plus platinum
Date of first enrollment2007/08/01
Target sample size220
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)CPT-11 Paclitaxel

Outcome(s)

Primary Outcomeoverall survival
Secondary Outcomeresponse rate, progression free survival, toxicity, rate of subsequent chemotherapy

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1.Histologically proven gastric adenocarcinoma 2.unresectable or recurrent gastric cancer refractory to one prior chemotherapy with fluorouracil plus platinum 3.No prior therapy of Taxane or CPT-11 4.No severe peritoneal metastasis 5.Age 20-75 years old 6.PS 0-2 7.>14 days after prior chemotherapy 8.no history of chemotherapy for other malignancy and radiation to abdomen 9.Adequate organ functions a) WBC>3000/mm3 and <12000/mm3 b) Hb>8.0g/dL c) Plt>10*104/mm3 d) AST.ALT<100IU/L e) T-Bil<1.5mg/dL f) Cre<1.5mg/dL 10.HBV(-) 11.Written informed consent
Exclude criteria1.Serious medical condition such as infection, heart disease 2.Massive pleural effusion or ascites or pericardial effusion 3.Hypersensitivity or neuropathy 4.Interstitial pneumonia 5.CNS metastasis 6.Pregnancy or breast-feeding

Related Information

Contact

public contact
Name Shinichiro Nakamura
Address Namba Plaza Bldg.3F 1-5-7,Motomachi Naniwa-ku,Osaka556-0016 JAPAN Japan
Telephone 06-6633-7400
E-mail datacenter@wjog.jp
Affiliation West Japan Oncology Group WJOG datacenter
scientific contact
Name Shuichi Hironaka
Address 666-2 Nitonacho Chuo-ku Chiba-shi Chiba 260-8717, Japan Japan
Telephone 043-264-5431
E-mail
Affiliation Chiba Cancer Center Division of Gastrointestinal Oncology