UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000184 |
|---|---|
| Receipt number | R000000258 |
| Scientific Title | Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2006/03/31 15:49:10 |
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Basic information
Public title
Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Acronym
Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Scientific Title
Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Scientific Title:Acronym
Phase II study of gefitinib in untreated advanced non-small cell lung cancer with EGF receptor mutations
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the efficacy and safety of gefitinib from the first line in patients with advanced non-small-cell lung cancer with EGF receptor mutations
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Toxicity
Survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gefitinib 250mg/day, until 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically proved NSCLC
2.EGFR mutation positive
3.No prior chemotherapy
4.Stage IIIB or IV disease
5.Measurable disease on RECIST criteria
6.ECOG PS 0 to 2
7.20 or more than 20 years of age
8.Normal organ functions
9.Anticipated survival at least 3 months
10.Written informed consent.
Key exclusion criteria
1.Serious concomitant systemic disorders
2.Uncontrollable angina, acute myocardial infarction or severe heart failure within 3 months
3.Uncontrollable diabetes mellitus or hypertension
4.Active infection
5.Interstitial pneumonia
6.Uncontrollable pleural effusion
7.Active ulcer
8.Active second malignancy
9.History of severe hypersensitivity
10.Severe SVC syndrome
11.Pregnancy
12.Other severe complication
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaharu Nishimura |
Organization
Hokkaido Lung Cancer Clinical Study Group
Division name
First Department of Medicine, Hokkaido University School of Medicine
Zip code
Address
North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL
011-706-5911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Yamazaki |
Organization
Hokkaido Lung Cancer Clinical Study Group
Division name
First Department of Medicine, Hokkaido University School of Medicine
Zip code
Address
North 15, West 7, Kitaku, Sapporo 060-8638, Japan
TEL
011-706-5911
Homepage URL
kyamazak@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
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
| 2005 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2004 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 12 | Day |
Last modified on
| 2006 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000258
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
