UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase II study of irinotecan + trastuzumab therapy as a second-line chemotherapy for unresectable advanced or recurrent gastric cancer with HER2 overexpression
Title of the study (Brief title)	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	Osamu Maedad
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-741-2111
Email	maeda-o@med.nagoya-u.ac.jp

Public contact
Name of contact person	Osamu Maedad
Organization	Nagoya University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	65 Tsurumai-cho Showa-ku Nagoya
TEL	052-741-2111
Homepage URL
Email	maeda-o@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009774