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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007409
Receipt No. 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

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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-na&iuml;ve 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
Email 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
Email yama-t@med.kawasaki-m.ac.jp

Sponsor
Institute NPO Japan Southwest Oncology Research Support Organization (JSWOG)
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006943

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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