UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004978 |
|---|---|
| Receipt number | R000005617 |
| Scientific Title | Phase I study of weekly intraperitoneal paclitaxel combined with oxaliplatin plus S-1 for advanced gastric cancer with peritoneal metastasis |
| Date of disclosure of the study information | 2011/01/29 |
| Last modified on | 2011/06/26 11:59:15 |
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Basic information
Public title
Phase I study of weekly intraperitoneal paclitaxel combined with oxaliplatin plus S-1 for advanced gastric cancer with peritoneal metastasis
Acronym
Phase I study of IP PTX plus SOX
Scientific Title
Phase I study of weekly intraperitoneal paclitaxel combined with oxaliplatin plus S-1 for advanced gastric cancer with peritoneal metastasis
Scientific Title:Acronym
Phase I study of IP PTX plus SOX
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 determine the maximum-tolerated dose (MTD) and recommended dose (RD) of SOX plus IP PTX
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
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 with an initial dose of 20 mg/m2, stepped up to 30 or 40 mg/m2. S-1 is administered at a fixed dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. Oxaliplatin is administered at a fixed dose of 100 mg/m2 on day1.
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 and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <1.5 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); 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
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironori Ishigami |
Organization
The University of Tokyo
Division name
Department of Outpatient Chemotherapy
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Department of Outpatient Chemotherapy
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
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 | 01 | Month | 29 | 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
| 2010 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | 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 | 01 | Month | 29 | Day |
Last modified on
| 2011 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005617
