UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis
Title of the study (Brief title)	PHOENIX-GC trial
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the superiority in overall survival of S-1 plus intravenous and intraperitoneal paclitaxel to S-1 plus cisplatin in gastric cancer patients with peritoneal metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	antitumor effect safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	S-1 plus intravenous and intraperitoneal paclitaxel
Interventions/Control_2	S-1 plus cisplatin
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologically proven primary gastric adenocarcinoma 2) Peritoneal metastasis confirmed by laparoscopy or diagnostic imaging 3) No or short-term (<2 months) prior chemotherapy 4) Adequate function of important organs (within 14 days before registration) Hemoglobin >=8.0g/dL WBC >= LLN, <12,000/mm3 Platelet >=100,000/mm3 T-Bilirubin <= ULN x 1.5 AST <=100U/L ALT <=100U/L Creatinine <= ULN 5) Eastern Cooperative Oncology Group performance status 0-1 6) Expected survival period of more than 3 months. 7) Age >=20, <75 8) Adequate oral intake 9) Written informed consent
Key exclusion criteria	1) Metastasis to distant organ sites other than the ovary 2) Contraindication to S-1, cisplatin or paclitaxel 3) Apparent infection or inflammation 4) Severe heart disease 5) Severe complication 6) Massive ascites requiring drainage for palliation 7) Gastrointestinal tract bleeding requiring blood transfusion 8) Severe diarrhea (more than 4 times a day and/or watery) 9) Psychiatric disorder requiring medication 10) Other active concomitant malignancies 11) Pregnancy, breast feeding or intention to become pregnant 12) Judged inappropriate for this trial for other reasons
Target sample size	180

Research contact person
Name of lead principal investigator	Hironori Ishigami
Organization	The University of Tokyo Hospital
Division name	Department of Chemotherapy
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	ishigami-tky@umin.net

Public contact
Name of contact person	Hironori Ishigami
Organization	The University of Tokyo Hospital
Division name	Department of Chemotherapy
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	ishigami-tky@umin.net

Sponsor
Institute	The University of Tokyo Hospital
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	2011 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 15 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date
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	2011 Year 07 Month 05 Day
Last modified on	2017 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007012