UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000408 |
|---|---|
| Receipt number | 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 10:29:53 |
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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
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
s_toyooka@nigeka2.hospital.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Cancer and Thoracic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000496
