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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005930
Receipt No. R000007012
Scientific Title Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis
Date of disclosure of the study information 2011/07/07
Last modified on 2017/01/07

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Basic information
Public title Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis
Acronym PHOENIX-GC trial
Scientific Title Phase III study of S-1 plus intravenous and intraperitoneal paclitaxel versus S-1 plus cisplatin for gastric cancer with peritoneal metastasis
Scientific Title:Acronym 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
1st name
Middle name
Last name Hironori Ishigami
Organization The University of Tokyo Hospital
Division name Department of Chemotherapy
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email ishigami-tky@umin.net

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Ishigami
Organization The University of Tokyo Hospital
Division name Department of Chemotherapy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 09 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000007012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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