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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005876
Receipt No. R000006580
Scientific Title Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)
Date of disclosure of the study information 2011/07/01
Last modified on 2014/08/04

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Basic information
Public title Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)
Acronym GCSPH
Scientific Title Combination treatment with TS-1+CDDP+Trastuzumab for unresectable HER 2 positive gastric cancer (A Phase II Study)
Scientific Title:Acronym GCSPH
Region
Japan

Condition
Condition Unresectable HER2 positive gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Antitumor efficacy
Key secondary outcomes Progression-free survival (PFS)
Overall survival (OS)
Antitumor efficacy
Adverse events

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 Chemotherapy with S-1(80mg/m2/day 14days), Cisplatin(20mg/m2/day day1,8), Trastuzumab(1st-8mg/kg 2nd-6mg/kg)
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 1. Gastric cancer confirmed by histology
2. Patients with unresectable or recurrent gastric cancer
3. HER2 positive confirmed by histology
(IHC(immunohistochemistry) 3+, or IHC 2+ and FISH (fluorescence in situ hybridization) positive))
4. Tumor lesion able to be measured
5. No prior radiotherapy, chemotherapy or hormone therapy
6. Performance Status (ECOG) 0-1
7. Age of 20 to 75
8. Patients with no peritoneal metastasis, intestinal obstruction and no acites
9. Sufficient oral intake
10. Adequate organ functions:
WBC >=3500/mm3 and <=12000/mm3,
neutrophils >=2000/mm3,
platelets >=100,000/mm3,
hemoglobin >=9.0g/dL,
total bilirubin <=1.5mg/dL,
AST(GOT)/ALT(GPT) within twice the normal upper limits
creatinin within the normal limits
creatinine clearance >=60mL/min.
11. Normal ECG and LVEF>=50%
12. Written informed consent.
Key exclusion criteria 1. patient who has drug allergy as past history
2. patient who needs flucytosine, phenytoin, and Warfarin
3. patient who has active infectious disease with fever over 38 degree
4. patient who has severe complication (interstitial pneumonia, DM, renal failure, liver failure under bad control)
5. watery diarrhea
6. Pleural effusion and acites
7. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart)
8.Uncontrolable hypertention
9. patient who has active double cancer
10. patient who want to be pregnant and /or pregnant woman
11. man who want to have a child
12. patient who was judged to be unsuitable for this clinical trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideaki Shimada
Organization Toho University School of Medicine
Division name Department of Surgery
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo
TEL 03-3762-4151
Email hideaki.shimada@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinori Kikuchi
Organization Toho University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 6-11-1 Omori-nishi Otaku Tokyo
TEL 03-3762-4151
Homepage URL
Email y-kikuchi@med.toho-u.ac.jp

Sponsor
Institute Toho University
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
2011 Year 07 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 Open public recruiting
Date of protocol fixation
2011 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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 06 Month 29 Day
Last modified on
2014 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006580

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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