UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013010 |
|---|---|
| Receipt number | R000015190 |
| Scientific Title | Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2018/10/24 11:03:14 |
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Basic information
Public title
Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases.
Acronym
Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases. (STOG1301)
Scientific Title
Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases.
Scientific Title:Acronym
Phase II study of bevacizumab in combined with carboplatin plus pemetrexed for patients with untreated non-squamous non-small cell lung cancer with brain metastases. (STOG1301)
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of bevacizumab in combined with carboplatin plus pemetrexed followed by bevacizumab and pemetrexed maintenance therapy for patients with untreated non-squamous non-small cell lung cancer with brain metastases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival (PFS)
Key secondary outcomes
Safety
RR; response rate
DCP; disease Control proportion
OS; overall survival
IPF; intracranial PFS
TBTF; time to Bev treatment failure
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
Carboplatin, pemetrexed and bevacizumab followed by maintenance pemetrexed and 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) Histologically or cytologically confirmed non-squamuous, non-small cell lung cancer and stage IV or recurrent non-small cell lung cancer
2) Brain metastasis. The number of Brain metastasis is not limited.
- Asymptomatic
- No bleeding or progress
- Neurosurgical extraction operation > 3 months
- The radiation therapy for the brain metastasis > 2 wks
- Diameter of maximum brain metastasis site < 1.5 cm
3) Untreated patient without adjuvant fluoropyrimidine or EGFR-TKI
- No prior Pemetrxed or Bevacizumab
4) Aged 20 years or over
5) ECOG Performance Status 0-1
6) With one or more measurable lesions based on RECIST version 1.1
7) Adequate organ function, as
- WBC > or = 4,000/mm3
- Neu > or = 2,000/mm3
- Plt > or = 10.0x10,000/mm3
- Hemoglobin > or = 9.0g/dL
- AST/ALT < or = 100 IU/L
- T-bil < or = 1.5mg/dL
- Cre < or = 1.2mg/dL
- Creatinine clearance > or = 45ml/min
- SpO2(Room air) > or = 90%
- Proteinuria < or = 1+
8) Interval
- Palliative radiotherapy > or = 2 wks
- Lobectomy Operation > or = 8 wks
- Another surgery > or = 4 wks
- Thoracic drainage, Pleurodesis > or = 2 wks
9) Written informed consent from the patients.
Key exclusion criteria
1) Antiedema agent treatment for a brain metastasis
2) Bleeding of the brain metastasis
3) Carcinomatous meningitis
4) Squamous cell dominant
5) Small cell lung carcinoma cells are contained.
6) Cerebral amyloid angiopathy
7) Current or previous history of hemoptysis
8) Current or previous history of continuing bloody sputum
- History of continuing bloody sputum within 3 months
- Current or previous history of continuing taking a oral hemostatic agent
- Need to treat intravenous hemostatic agent for sputum
9) Have received radiation therapy to lesions of the lung
10) Have received therapy to primary lesion
11) Evidence of tumor invading large vessel on imaging
12) Severe infection
13) Severe complications
14) Uncontrolled ascites, pleural effusion or pericardial effusion
15) Active concomitant malignancy
16) History of severe drug allergy
17) Active interstitial pneumonitis or pulmonary fibrosis on chest CT scans
18) Uncontrollable hypertension < 160/100
19) History of symptomatic cerebrovascular disease
20) Need to antiplatelet therapy or anticoagulation therapy without Aspirin 325 mg/day
21) Uncontrolled ulcer
22) Gastrointestinal perforation within 1 year
23) Inappropriate for this study judged by the attending physician
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
International University of Health and Werfare
Division name
Respiratory Disease Center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
snagase@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seisuke Nagase |
Organization
International University of Health and Werfare
Division name
Respiratory Disease Center
Zip code
Address
1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL
03-3451-8121
Homepage URL
snagase@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Werfare,
Respiratory Disease Center
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
慶応義塾大学病院 呼吸器内科 (東京都）
国立国際医療研究センター 呼吸器内科 (東京都）
JR東京総合病院 呼吸器内科（東京都）
東京女子医科大学病院 呼吸器内科 (東京都）
東京医科大学病院 呼吸器・甲状腺外科 (東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | 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 | 01 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015190
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