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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000408
Receipt No. R000000496
Scientific Title Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study
Date of disclosure of the study information 2006/04/24
Last modified on 2011/04/24

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Basic information
Public title Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study
Acronym Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study
Scientific Title Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study
Scientific Title:Acronym Gefitnib monotherapy in patients with post-operative recurrent non-small-cell lung cancer with the EGFR mutation: a Phase II study
Region
Japan

Condition
Condition non small cell lung cancer with EGFR mutation
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To determine the efficacy of gefitinib in patients with NSCLC with EGFR mutation in the setting of postoperative recurrent disease.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes tumor response rate
Key secondary outcomes 1)Adverse events
2)Progression free-survival
3)Overall survival

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 Oral administration of 250 mg/day of 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically confirmed NSCLC
2) With measurable or evaluable disease
3) Postoperative recurrent disease
4) With EGFR mutation of exon 19 or 21 in cancer tissue
5) >= 4weeks after prior treatment
6) ECOG PS 0-1
7) Expected survival over 3 months
8) Sufficient organ functions
white blood cell count >=3000/uL
neutrophil count >=1500/uL
platelet count >=100000/uL
hemoglobin >= 8.5 g/dl
GOT and GPT < 2.5x upper normal limit
serum bilirubin level <= 1.5 mg/dl
serum creatinine level <= 1.5 mg/dl
PaO2 >= 60 mmHg
9) Provided written informed consent
Key exclusion criteria 1)EGFR mutations except exon19 deletion and exon21 mutation (L858R) or double mutation.
2)Serious infectious disease
3) Brain metastases requiring treatment
4) Serious concomitant disease
5) Ascites, pleural or pericardeal effusion requiring drainage
6)Pregnant or lactation women, or women with known or suspected pregnancy
7) Apparent ineterstitial pneumonia or pulmonary fibrosis
8) Prior treatment of gefitinib
9) Requiring emergency radiotherapy
Cardiac infarction within 6 month
10)Inappropriate patients for this study judged by the physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miyoshi Sinichiro
Organization Okayama University
Division name Cancer and Thoracic Surgery
Zip code
Address 2-5-1 Shikata-cho, Okayama City
TEL 086-235-7265
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Toyooka
Organization Okayama University
Division name Cancer and Thoracic Surgery
Zip code
Address 2-5-1 Shikata-cho, Okayama City
TEL 086-235-7265
Homepage URL
Email s_toyooka@nigeka2.hospital.okayama-u.ac.jp

Sponsor
Institute Okayama University Cancer and Thoracic Surgery
Institute
Department

Funding Source
Organization N/A
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

Other administrative information
Date of disclosure of the study information
2006 Year 04 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
Date of protocol fixation
2006 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 02 Month 01 Day
Last follow-up date
2010 Year 12 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 04 Month 24 Day
Last modified on
2011 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000496

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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