UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005930 |
|---|---|
| Receipt number | 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 09:10:05 |
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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
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
ishigami-tky@umin.net
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007012
