UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008292 |
|---|---|
| Receipt number | R000009774 |
| Scientific Title | A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression |
| Date of disclosure of the study information | 2012/06/29 |
| Last modified on | 2018/07/04 18:15:50 |
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Basic information
Public title
A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Acronym
A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Scientific Title
A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Scientific Title:Acronym
A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent gastric cancer with HER2 overexpression
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation for safety and efficacy of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Adverse events, overall survival, response rate
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
Irinotecan 150mg/m2 day1 every 2 weeks
Trastuzumab 6mg/kg day1 every 3 weeks
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. Unresectable gastric cancer with HER2 overexpression (HER2 IHC 3+, or IHC 2 and FISH+) after first-line chemotherapy with fluorouracil + cisplatin + trastuzumab
2. Stage IV
3. ECOG performnce status 0-2
4. WBC>=3,000/microl
5. Neutrophil>=1,500/microl
6. Hemoglobin>=8.0g/dl
7. Platelet>=100,000/microl
8. Total bilirubin<=1.5mg/dl
9. AST(GOT)<=100 (<=200 if presence of liver metastasis)
10. ALT(GPT)<=100 (<=200 if presence of liver metastasis)
11. Serum creatinine<=2.0mg/dl
12. Ejection fraction on echo cardiogram>=50%
Key exclusion criteria
1. HER2 IHC- or IHC1+, or IHC2+/FISH-
2. Ejection fraction on echo cardiogram<=50%
3. Discontinuation of trastuzumab in first-line chemotherapy due to adverse reaction of trastuzumab
4. Intestinal paralysis or ileus
5. Uncontrolled diarrhea
6. Massive ascites or pleural effusion
7. Chronic lung disease: interstitial pneumonia, pulmonary fibrosis, or severe emphysema
8. Uncontrolled diabetes
9. Uncontrolled hypertension
10. Unstable angina pectoris, or a history of myocardial infarction within six months
11. Synchronous cancers
12. Systemic infection requiring treatment
13. Fever above 38 degree Celsius
14. A possibility of pregnancy or during pregnancy, or lactating women
15. Psychosis or psychotic symptoms
16. Continuous systemic administration of steroids (oral or intravenous)
17. Hypersensitivity to ingredients of irinotecan or trastuzumab
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Maedad |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
maeda-o@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Maedad |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho Showa-ku Nagoya
TEL
052-741-2111
Homepage URL
maeda-o@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 06 | Month | 29 | 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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 26 | 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 | 06 | Month | 29 | Day |
Last modified on
| 2018 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009774
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