NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000246

Registered date:22/09/2005

Paclitaxel plus cisplatin and concurrent radiation for unresectable, locally recurrent or remnant gastric cancer in the left upper abdomen – phase I study

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedunresectable, locally recurrent or remnant gastric cancer
Date of first enrollment2005/09/01
Target sample size6
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Treatments consisted of chemotherapy of biweekly paclitaxel plus cisplatin and concurrent radiation for 5 weeks for unresectable, locally recurrent or remnant gastric cancer.

Outcome(s)

Primary OutcomeRecommended dose
Secondary Outcome1) Dose-limiting toxicities 2) Maximum-tolerated dose 3) The improved rate of bowel stenosis 4) The improved rate of pain relief 5) Overall survival

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1) Local tumor is not identified by computerized tomography (CT), endoscope or gastrointestinal examination 2) Other severe medical conditions 3) Patients need treatments for bowel obstruction or bleeding 4) Obvious infection or acute inflammatory condition 5) Allergy to drugs containing Cremophor EL (including cyclosporin) 6) Brain metastases with clinical symptom 7) Women who is pregnant, lactating or have the possibility of pregnancy 8) Patients who is judged inappropriate by lead principal investigator

Related Information

Contact

public contact
Name Masayuki Kimura
Address 22-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, Japan. Japan
Telephone 044-977-8111
E-mail m2kimura@marianna-u.ac.jp
Affiliation St.Marianna University School of Medicine Hospital The Department of Gastrointestinal Surgery
scientific contact
Name Takaki Yoshikawa
Address 1-1-2 Nakao, Asahi-ku, Yokohama-shi, 241-0815, Japan Japan
Telephone 045-391-5761
E-mail
Affiliation Kanagawa Cancer Center The Department of Gastrointestinal Surgery