UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013586 |
|---|---|
| Receipt number | R000015870 |
| Scientific Title | Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2014/09/01 19:24:13 |
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Basic information
Public title
Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance
Acronym
BAGEL study
Scientific Title
Randomised phase 2 trial of gefitinib plus bevacizumab vs gefitinib alone in patients with EGFR mutant non-squamous non small cell lung cance
Scientific Title:Acronym
BAGEL study
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 compare the efficacy and safety of gefitinib with gefitinib plus bevacizumab for chemotherapy-naive advanced EGFR activating mutation positive non small cell lung cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Overall survival, Response rate, Disease control rate, Toxicity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
gefitinib
Interventions/Control_2
gefitinib plus bevacizumab
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) Patients with lung cancer which was pathologically proven non-squamous non small cell lung cancer
2) harboring activating mutation of EGFR gene (exon 19 delation, and L858R)
3) advanced (stage IIIB who can not treat radiation therapy, and stage IV) or reccurent NSCLC patients
4) No prior chemotherapy or EGFR-TKI
5) 20 years old or more
6) ECOG PS 0-2
7) Measureable region evaluable
8) Sufficient organ function
9) over 3 months of lifetime expectancy
10) Written informed consent
Key exclusion criteria
1) History of drug induced interstitial pneumonia or radiation pneumonitis that need steroid therapy. Interstitial pneumonitis or pulmonary fibrosis as determined from chest CT
2) EGFR mutation that associates with gefitinib resistance (exon 20 T790M)
3) central nervous system metastases
4) spinal cord compression
5) Active concomitant malignancy
6) Currently have or have a history of hemoptysis
7) bleeding tendency (coagulation disorder)
8) Patients receiving therapeutic anticoagulation
9) Uncontrolled effusion (Pleural, peritoneal effusion, or cardiac effusion which requires drainage for symptom management)
10) History of gastrointestinal perforation
11) History of serious systemic disease including: clinically significant cardiovascular disease; medically uncontrolled diabetes and hypertension; active gastrointestinal ulcer, acive psychological disorders
12) Clinically significant drug allergy
13) Serious concomitant active infection
14) Receiving systemic corticosteroid therapy within 2 weeks of registration
15) Major surgery within 3 weeks of registration, radiotherapy within 2 weeks of registration
16) Pregnant or breast-feeding woman
17) Not suitable for participating in the study for any other reason
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo Saka |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of Respiratory Medicine & Medical oncology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, 460-0001, JAPAN
TEL
052-951-1111
saka@nagoya.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiyoe Kitagawa |
Organization
National Hospital Organization Nagoya Medical Center
Division name
Department of medical oncology & Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi, 460-0001, JAPAN
TEL
052-951-1111
Homepage URL
kitagawc@nnh.hosp.go.jp
Sponsor or person
Institute
BAGEL study group
Institute
Department
Personal name
Funding Source
Organization
NPO-OSCR
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 23 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015870
