UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000376 |
|---|---|
| Receipt number | R000000432 |
| Scientific Title | Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations |
| Date of disclosure of the study information | 2008/12/31 |
| Last modified on | 2010/09/28 12:41:35 |
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Basic information
Public title
Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations
Acronym
Gefitinib vs CBDCA/TXL in untreated NSCLC with EGFR mutations
Scientific Title
Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations
Scientific Title:Acronym
Gefitinib vs CBDCA/TXL in untreated NSCLC with EGFR mutations
Region
| Japan |
Condition
Condition
Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the superiority of gefitinib to carboplatin/paclitaxel in the first line treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival, response rate, toxicity, Quality of Life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gefitinib
Interventions/Control_2
Carboplatin/Paclitaxel
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.Histologically or cytologically proven NSCLC
2.With EGFR gene mutations
3.With measurable lesion (RECIST)
4.With no prior chemotherapy
5.PS (ECOG) 0 or 1
6.With adequate organ functions
7.With life expectancy over 3 months
8.With written informed consent
Key exclusion criteria
1.With lung fibrosis detectable in chest CT
2.With gefitinib resistant EGFR mutation (T790M)
3.With symptomatic brain metastasis
4.Previous radiotherapy to primary lung cancer
5.With severe co-morbidities
6.With active double cancer
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Nukiwa |
Organization
Tohoku University School of Medicine
Division name
Respiratory Medicine
Zip code
Address
1-1, Seiryomachi, Aobaku, Sendai
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NEJ Gefitinib Study Group
Division name
Secretariat
Zip code
Address
TEL
022-717-8539
Homepage URL
Sponsor or person
Institute
NEJ Gefitinib Study Group
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 12 | Month | 31 | 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
| 2006 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | 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
| 2006 | Year | 03 | Month | 28 | Day |
Last modified on
| 2010 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000432
