UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007409 |
|---|---|
| Receipt number | R000006943 |
| Scientific Title | Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2017/03/09 15:21:41 |
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Basic information
Public title
Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Acronym
Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Scientific Title
Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Scientific Title:Acronym
Feasibility study of S-1 and CDDP chemotherapy with short hydration for advanced Gastric Cancer
Region
| Japan |
Condition
Condition
advanced and/or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility of S-1+CDDP chemotherapy with short hydration
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
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
S-1 is orally administered for 21 days followed by 14 days rest according to body surface area. CDDP is administered intravenously in each dosage of level at day 8 .
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven adenocarcinoma of advanced gastric cancer(included esophagogastric junction)
2)CDDP-naïve patients
3)ECOG Performance status(PS) of 0-1.
4)Age of 20 years or older.
5 ) Life expectancy is less than 3 months
6)no severe organ failure
7) possible to oral intake
8) written informed consent
Key exclusion criteria
(1) Patient with administration contraindication of S-1 or CDDP
(2,3,4,5) pts with active co-morbidities including severe conditions of heart diseases, gastric ulcers, infections, ileus, uncontrollable diabetes, hypertension, renal failure, hepatic cirrhosis, active interstitial.
(6) Symptomatic pleural effusion or ascites
(7) metastasis to the brain
(8) Watery diarrhea
(9) Symptomatic psychological disease
(10)Concomitant therapy with flucytocine or phenytoin
(11)Pregnancy or breast feeding
(12)Decision as ineligible by principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Naomoto |
Organization
Kawasaki Medical School
Division name
Department of General Surgery
Zip code
Address
2-6-1, Nakasange, Kita-Ward, Okayama-City, Okayama-Prefecture
TEL
086-225-2111
ynaomoto@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Yamatsuji |
Organization
Kawasaki Medical School
Division name
Department of General Surgery
Zip code
Address
2-6-1 Nakasange, Kita-ku, Okayama City, Okayama, 700-8505, Japan
TEL
086-225-2111
Homepage URL
yama-t@med.kawasaki-m.ac.jp
Sponsor or person
Institute
NPO Japan Southwest Oncology Research Support Organization (JSWOG)
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2012 | Year | 03 | 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
| 2011 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | 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
| 2012 | Year | 02 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006943
