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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001738
Receipt No. 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

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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
Email 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
Email skanda@ncc.go.jp

Sponsor
Institute Thoracic Medical Oncology, National Cancer Center Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002091

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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