UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004296 |
|---|---|
| Receipt number | R000005134 |
| Scientific Title | A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2012/10/17 19:11:33 |
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Basic information
Public title
A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Acronym
A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Scientific Title
A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Scientific Title:Acronym
A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of the combination chemotherapy (gefitinib and bevacizumab) in advanced non-small cell lung cancer with mutated EGFR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PFS
Key secondary outcomes
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, bevacizumab
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. pathologically proven non-squamous non-small cell lung cancer
2. harboring active EGFR mutation other than exon 20 T790M
3. stage IV or ineligibility as candidates for curative treatment
4. measurable tumor sites
5. no prior chemotherapy
no prior systemic anticancer therapy
6. ECOG PS of 0 to 1
7. appropriate organ function
8. expected to live for more than 3 months
9. acquisition of written informed consent
Key exclusion criteria
1. symptomatic brain metastasis
2. pts with hemoptysis with 2.5mL or more
3. pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion
4. pts with bleeding tendency
pts who need continuous use of antithrombotic agents
5. candidate for curative radiation therapy
6. have a history of severe drug allergy
7. woman who is pregnant or wishing to become pregnant
8. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
9. pts with active co-morbidities including severe conditions of heart diseases, infections, uncontrollable diabetes, uncontollable hypertension, interstitial pneumonia, active hepatitis and thrombotic disease.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
Homepage URL
Sponsor or person
Institute
Okayama Lung Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2010 | Year | 10 | Month | 01 | 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
| 2010 | Year | 09 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 29 | Day |
Last modified on
| 2012 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005134
