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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023620
Receipt No. R000027201
Scientific Title Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Date of disclosure of the study information 2016/10/01
Last modified on 2017/02/22

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Basic information
Public title Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Acronym PR-PHOENIX trial
Scientific Title Clinical research of S-1 plus intravenous and intraperitoneal paclitaxel for gastric cancer with peritoneal metastasis or positive peritoneal cytology
Scientific Title:Acronym PR-PHOENIX trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of S-1 plus intravenous and intraperitoneal paclitaxel in gastric cancer patients with peritoneal metastasis or positive peritoneal cytology
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety
Key secondary outcomes overall survival
response rate
negative conversion rate on peritoneal cytology

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 intraperitoneal PTX 20 mg/m2, intravenous PTX 50 mg/m2 on days 1 and 8, S-1 80 mg/m2/day on days 1-14, q3 weeks
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

Not applicable
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Pathologically proven primary gastric adenocarcinoma
2) Peritoneal metastasis or positive peritoneal cytology
3) Adequate function of important organs (within 14 days before registration)
NEU >=1,000/mm3
Hemoglobin >=8.0g/dL
Platelet >=75,000/mm3
AST <=150U/L, ALT <=150U/L
T-Bilirubin <=3.0mg/dL
Creatinine clearance >=30mL/min
4) Eastern Cooperative Oncology Group performance status 0-2
5) Age >= 20, < 75 years
6) Written informed consent
Key exclusion criteria 1) Distal metastasis other than to the peritoneum, ovary and abdominal lymph nodes
2) Contraindication to S-1 or paclitaxel
3) Apparent infection or inflammation
4) Severe heart disease
5) Severe complication
6) Gastrointestinal tract bleeding requiring blood transfusion
7) Pregnancy, breast feeding or intention to become pregnant
8) Judged inappropriate for this trial for other reasons
Target sample size 100

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 University of Tokyo
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 10 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 14 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
2016 Year 08 Month 14 Day
Last modified on
2017 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027201

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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