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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003354
Receipt No. R000004072
Scientific Title A phase II study of carboplatin plus pemetrexed followed by gefitinib for stage IIIB/IV non-small cell lung cancer with EGFR mutation
Date of disclosure of the study information 2010/03/23
Last modified on 2016/03/18

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Basic information
Public title A phase II study of carboplatin plus pemetrexed followed by gefitinib for stage IIIB/IV non-small cell lung cancer with EGFR mutation
Acronym carboplatin, pemetrexed and gefitinib for lung cancer with EGFR mutation
Scientific Title A phase II study of carboplatin plus pemetrexed followed by gefitinib for stage IIIB/IV non-small cell lung cancer with EGFR mutation
Scientific Title:Acronym carboplatin, pemetrexed and gefitinib for lung cancer with EGFR mutation
Region
Japan

Condition
Condition non-small cell lung cancer with EGFR mutation
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of carboplatin plus pemetrexed followed by gefinitib for patients of stage IIIB/IV non-small cell lung cancer with EGFR mutation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year survival rate
Key secondary outcomes overall survival, progression-free survival, anti-tumor effect, toxicity

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 carboplatin, pemetrexed, gefitinib
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 Patients with histologically or cytologically confirmed NSCLC with EGFR mutation, clinical stage IIIB or IV, an expected survival of at least 12 weeks, age >20 years and < 75 years, Eastern Cooperative Oncology Group PS score 0-1, leukocyte count>=4,000/mm2, hemoglobin >=10 g/dl, platelet count >=100,000/mm2, total serum bilirubin <=1.5 mg/dl, aspartate aminotransferase and alanine aminotransferase <100 IU/L, serum creatinine <=1.5 mg/dl. Patients who had experienced postoperative recurrence were eligible, written informed consent was obtained from every patient.
Key exclusion criteria Patients who had received chemotherapy or radiotherapy were excluded.
Patients who have massive pleural effusion or pericardial effusion, who have uncontrolled cardiac disease, diabetes mellitus or hypertension, who have infectious disease, who have interstitial pneumonitis, were excluded.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouzo Yamada
Organization Kanagawa Cancer Center
Division name Thoracic Oncology
Zip code
Address Nakao 2-3-2, Asahi-ku, Yokohama 241-0815, Japan
TEL +81-45-520-2222
Email yamakak@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fumihiro Oshita
Organization Kanagawa Prefectual Ashigarakami Hospital
Division name Comprehensive Medical Care
Zip code
Address Matsudasouryo 866-1, Matsuda-machi, Kanagawa 258-0003
TEL +81-465-83-0351
Homepage URL
Email foshita@ashigarakami-hospital.jp

Sponsor
Institute Kanagawa Cancer Center
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 神奈川県立がんセンター

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 23 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
2010 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
2017 Year 03 Month 01 Day
Date trial data considered complete
2017 Year 05 Month 01 Day
Date analysis concluded
2017 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 18 Day
Last modified on
2016 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004072

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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