UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005792 |
|---|---|
| Receipt number | R000006849 |
| Scientific Title | Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer: a phase II trial. |
| Date of disclosure of the study information | 2011/06/17 |
| Last modified on | 2016/10/24 19:24:35 |
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Basic information
Public title
Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer: a phase II trial.
Acronym
Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer.
Scientific Title
Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer: a phase II trial.
Scientific Title:Acronym
Trastuzumab incombination with S-1/CDDP of HER2-positive advanced gastric cancer.
Region
| Japan |
Condition
Condition
HER2 positive gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
one year survival rate
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/CDDP+Trastuzumab
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. case which was diagnosed as gastric cacner by histopathologically.
2. Stage IV gastric cancer
3. HER2 positive (IHC 3+ or IHC 2+ and FISH positive)
4. age 20-80 Y
5. ECOG PS:0-2
6. case which has lesions to be evaluated
7. patient who is possible of ingestion
8. initial treatment case (patient who had adjuvant chemotherapy by TS-1 more than 24 weeks ago)
9. patient who is expected to be survival more than 3 months
10. LVEF>50% by UCG
11.
WBC:3,000 / mm3-12,000 / mm3
Neutro:>1,500/mm3
Plt:>100,000/mm3
Hb:>9.0 g/dl
AST(GOT),ALT(GPT):>100 IU / l
T-Bil:<2.0mg / dl
C.Cr:>60ml / min (Cockcroft- Gault)
12. patient who was taken IC by document.
Key exclusion criteria
1. patient who has drug allergy as past history
2. case of administration contraindication
3. patient who needs flucytosine, phenytoin, and Warfarin
4. patient who has active infectious disease with fever over 38 degree
5. patient who has severe complication (intestinal palsy, ileus, interstitial pneumonia, DM, renal failure, liver failure under bad control)
6. patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a
valvular disease of the heart)
7. patient who has metastatic brain tumor with symptoms
8. watery diarrhea
9. severe ascites and/or pleural effusion
10. patient who has active double cancer
11. patient who want to be pregnant and /or pregnant woman
12. man who want to have a child
13. patient who was not judged to be suitable for this clinical trial
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Kataoka |
Organization
Nagoya City University Hospital
Division name
Dept. of Gastroenterology, Div. of Endoscopy
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8211
hkataoka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Kataoka |
Organization
Nagoya City University Hospital
Division name
Dept. of Gastroenterology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya,Japan
TEL
052-853-8211
Homepage URL
hkataoka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Dept. of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya Daini Red Cross Hospital, Nagoya City East Medical Center, West Medical Center, Bisai Hospital, NTT West Tokai Hospital, Toyokawa City Hospital, Asahi Rousai Hospital, Tajimi Hospital,Gamagoori Municipal Hospital
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
名古屋市立大学病院（愛知県），名古屋第二赤十字病院（愛知県），名古屋市立東部医療センター（愛知県），名古屋市立西部医療センター（愛知県），愛知県厚生農業協同組合連合会尾西病院（愛知県），NTT西日本東海病院（愛知県），豊川市民病院（愛知県），旭労災病院（愛知県），岐阜県立多治見病院（岐阜県），社会保険中京病院（愛知県），蒲郡市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
Kataoka H, Mori Y, Shimura T, Nishie H, Natsume M, Mochizuki H, Hirata Y, Sobue S, Mizushima T, Sano H, Mizuno Y, Nakamura M, Hirano A, Tsuchida K, Adachi K, Seno K, Kitagawa M, Kawai T, Joh T. A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer. Cancer Chemother Pharmacol. 2016 May;77(5):957-62.
Management information
Registered date
| 2011 | Year | 06 | Month | 16 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006849
