UMIN-CTR Clinical Trial

Basic information
Public title	Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib
Acronym	Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib
Scientific Title	Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib
Scientific Title:Acronym	Immunohistochemical analysis of EGFR, HER2 and their phosphorylated status, and Insulin-like growth factor-1 receptor in tumor tissues obtained from non-small cell lung cancer patients treated with gefitinib
Region	Japan

Condition
Condition	gefitinib in patients with NSCLC
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib in patients with NSCLC
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and efficacy of gefitinib
Key secondary outcomes	Relationships between EFGR, HER2, phosphorylated EGFR, phosphorylated HER2, IGF-1R expressions and disease control rate or safety of gefitinib

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	gefitinib 250mg/m2 EGFR orally per day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) NSCLC 2) Chemonaive or prior 1-2 regimens of chemotherapy 3) At least one measurable lesion 4) Availability of tissue sample for immunohistochemical analyses 5) Age > 20 years 6) Adequate main organ functions 7) Performance status (PS) of 0 to 2 8) Written informed consent
Key exclusion criteria	1) Gefitinib with concurrently other chemotherapy 2) Need of curable radiation therapy to primary lesion. 3) Need of radiation therapy to the biopsy lesion for tissue samples for immunohistochemical analyses 4) Old tissue sample (before 2 regimens from the gefitinib therapy) for immunohistochemical analyses and no way to gain a new tissue sample 5) No estimation of at least 3 months survival 6) Intestinal pneumonia or lung fibrosis 7) History of severe drug allergic reaction 8) Severe infection and complication (cardio insufficiency or hemorrhage etc.) 9) Severe diarrhea 10) Bowel obstruction 11) Symptomatic brain metastasis 12) History of other malignancy 13) Pregnant women or women willing child-bearing 14) No regulatory condition because of psychological disease 15) Inadequate condition diagnosed by primary physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenji Tamura MD
Organization	Kinki University School of Medicine, Nara Hospital
Division name	Department of Medical Oncology
Zip code
Address	Otoda, Ikoma, Nara, 630-0293, Japan
TEL	0743-77-0880
Email

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
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	2005 Year 09 Month 07 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	2003 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date	2003 Year 12 Month 01 Day
Last follow-up date	2007 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 07 Day
Last modified on	2016 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000188

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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