UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001738 |
|---|---|
| Receipt number | R000002091 |
| Scientific Title | Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation |
| Date of disclosure of the study information | 2009/03/01 |
| Last modified on | 2013/09/05 15:16:46 |
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Basic information
Public title
Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Acronym
Phase II study of gefitinib therapy inserted by chemotherapy for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Scientific Title
Phase II study of gefitinib therapy inserted by chemotherapy as first line treatment for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Scientific Title:Acronym
Phase II study of gefitinib therapy inserted by chemotherapy for advanced non-small cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the treatment with gefitinib for 8weeks, followed by chemotherapy (cisplatin/ docetaxel 3cycles), then gefitinib again for chemotherapy-naive advanced or postoperative-recurrent non-small-cell lung cancer harboring epidermal growth factor receptor (EGFR) mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-years progression free survival rate
Key secondary outcomes
Response rate
Overall survival
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
1) Gefitinib 250mg/day orally for 8weeks
2) Gefitinib cessation for 2weeks
3) Chemotherapy (every 21days, 3cycles)
Cisplatin 80 mg/m2 day1
Docetaxel 60 mg/m2 day1
4) Gefitinib 250mg/day orally until intolerable toxicity or disease progression
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
1) Pathologically confirmed, stage IIIB/IV or post-operative recurrent non-small-cell lung cancer
2) EGFR somatic mutation (exon 19 DEL or exon 21 L858R) (regardless of the sampling and analysis method)
3) No prior chemotherapy (Patients who had taken oral UFT as adjuvant chemotherapy and finished the therapy more than 4weeks ago are eligible)
4) In post-operative recurrent case, 4weeks or longer blank after operation is needed
5) Age over 20 and under 75 years old
6) ECOG performance status 0-2
7) Life expectancy of 12weeks or longer
8) Adequate organ function
9) Written informed consent
(Patients who received pleural effusion drainage, pleurodesis, and local palliative radiation therapy are eligible, but patients who received pericardiac effusion drainage are ineligible.)
Key exclusion criteria
1) EGFR mutation that associates with gefitinib resistance (exon 20 T790M) or K-ras mutation
2) CNS metastasis requiring treatment
3) Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT
4) Complications like below
a) Active infection
b) Acute myocardial infarction, the other severe heart diseases, and arrhythmia within the previous 6months
c) Uncontrollable diabetes mellitus
d) Uncontrollable hypertension
e) Continuous diarrhea and ileus
f) Psychological disorders difficult to cooperate in the clinical trial
5) Receiving systemic corticosteroid therapy
6) Active metachronous cancer (disease-free survival of less than 5years)
7) Pregnancy or breast-feeding
8) No intent to practice contraception
9) Difficult to take medicine continuously
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohide Tamura |
Organization
National Cancer Center Hospital
Division name
Thoracic Medical Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
ttmaura@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ohe, Shintaro Kanda |
Organization
National Cancer Center Hospital
Division name
Thoracic Medical Oncology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
skanda@ncc.go.jp
Sponsor or person
Institute
Thoracic Medical Oncology, National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2009 | Year | 03 | Month | 01 | 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
| 2008 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002091
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