NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000636

Registered date:30/08/2008

The efficacy and feasibility of the repeated intraperitoneal Paclitaxel +systemic TS-1 and Paclitaxel for far advanced or recurrent gastric cancer: Phase I/II trial.

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedFar advanced or recurrent gastric cancer
Date of first enrollment2006/08/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)1.Oral TS-1 80mg/m2 every day 2.Intravenous Paclitaxel 50mg/m2 every week 3.intraperitoneal Paclitaxel every week 2 week administration and 1 week off x3 cycles

Outcome(s)

Primary Outcomeside effects 1-year survival
Secondary Outcomeplasma level of taxol response rate Duration of overall Response Duration of complete Response Duration of Stable DiseaseTime To Progression

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderMale and Female
Include criteriaNon-resectable gastric cancer with peritoneal dissemination, or positive peritoneal cytology.
Exclude criteriaOther hematogeneous metastasis multiple cancers other cases who are decided to be inappropriate for the clinical trial by doctors.

Related Information

Contact

public contact
Name Joji Kitayama
Address Hongo 7-3-1, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411
E-mail kitayama-1SU@h-u-tokyo.ac.jp
Affiliation The University of Tokyo Department of Surgical Oncology
scientific contact
Name Joji Kitayama
Address Hongo 7-3-1, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411.33246
E-mail
Affiliation The University of Tokyo Department of Surgical Oncology