UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003354 |
|---|---|
| Receipt number | 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 11:13:38 |
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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
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
foshita@ashigarakami-hospital.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004072
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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