UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023000 |
|---|---|
| Receipt number | R000026511 |
| Scientific Title | Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for advanced gastric cancer with peritoneal metastasis |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2020/03/30 18:23:26 |
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Basic information
Public title
Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for advanced gastric cancer with peritoneal metastasis
Acronym
Phase II study of SP+IP PTX
Scientific Title
Phase II study of intraperitoneal paclitaxel combined with S-1 plus cisplatin for advanced gastric cancer with peritoneal metastasis
Scientific Title:Acronym
Phase II study of SP+IP PTX
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 efficacy and safety of intraperitoneal paclitaxel combined with S-1 plus cisplatin for gastric cancer patients with peritoneal metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year overall survival
Key secondary outcomes
response rate
negative conversion rate on peritoneal cytology
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
PTX is administered intraperitoneally at 20 mg/m2 on days 1,8 and 22.
S-1 is administered at 80 mg/m2/day for 21 consecutive days, followed by 14 days rest.
Cisplatin is administered at 60 mg/m2 on day8.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-1; adequate bone marrow function (leukocyte count 3,300-12,000/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); Ccr>=60mL/min; 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
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumaicho Show-ku Nagoya
TEL
052-744-2233
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Kobayashi |
Organization
Nagoya University
Division name
Department of Gastroenterological Surgery
Zip code
Address
65 Tsurumaicho Show-ku Nagoya
TEL
052-744-2249
Homepage URL
kobadai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 08 | 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
| 2017 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026511
