UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005876 |
|---|---|
| Receipt number | 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 | 2021/08/14 16:42:47 |
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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
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
y-kikuchi@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
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
| 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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 31 | Day |
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
| 2021 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006580
