UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis
Title of the study (Brief title)	Phase I/II study of intravenous and intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin for advanced gastric cancer with peritoneal metastasis
Region	Japan

Condition
Condition	advanced gastric cancer with peritoneal metastasis
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and tolerability of intraperitoneal paclitaxel combined with continuous intraperitoneal cisplatin in gastric cancer patients with peritoneal metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	safety the 1-year overall survival rate
Key secondary outcomes	the overall response rate, efficacy against peritoneal metastasis and safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	In the phase I study, paclitaxel is administered intravenously on days 1 and 15 at a fixed dose of 100 mg/m2, and intraperitoneally with an initial dose of 20 mg/m2, stepped up to 30 or 40 mg/m2. Cisplatin is administered intraperitoneally over 1 hour at a fixed dose of 30 mg/m2. In the phase II study, paclitaxel is administered intraperitoneally at the recommended dose.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <2.0 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.
Key exclusion criteria	Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.
Target sample size	25

Research contact person
Name of lead principal investigator	Hironori Ishigami
Organization	The University of Tokyo
Division name	Department of Surgical Oncology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person	Hironori Ishigami
Organization	The University of Tokyo
Division name	Department of Surgical Oncology
Address
TEL
Homepage URL
Email	ishigami-tky@umin.net

Sponsor
Institute	Department of Surgical Oncology, The University of Tokyo
Institute
Department

Funding Source
Organization	The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2009 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 05 Month 28 Day
Anticipated trial start date	2009 Year 06 Month 01 Day
Last follow-up date	2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 07 Month 27 Day
Last modified on	2017 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002764