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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000126
Receipt No. R000000188
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
Date of disclosure of the study information 2005/09/07
Last modified on 2016/09/27

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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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