UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004368 |
|---|---|
| Receipt number | R000005222 |
| Scientific Title | Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016) |
| Date of disclosure of the study information | 2010/10/12 |
| Last modified on | 2013/10/14 13:37:48 |
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Basic information
Public title
Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Acronym
Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Scientific Title
Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Scientific Title:Acronym
Multicenter phase II study of docetaxel/cisplatin/bevacizumab combination therapy in patients with advanced non-squamous non-small cell lung cancer (TORG1016)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of docetaxel/cisplatin/bevacizumab combination therapy in patients with non-squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
adverse events, progression free survival, 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
docetaxel/cisplatin/bevacizumab combination therapy
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) pathologically diagnosed non-squamous non-small cell cancer
2) stage III/IV without indication for curative radiothrapy or post-operative reccurent disease
3) aged 20 years or older, under 75 years
4) ECOG PS: 0-1
5) measurable lesion meeting RECIST criteria (version 1.1)
6) no prior treatment except for surgery,EGFR-TKI, palliative radiotherapy
7) adequate organ function
8) life expectancy more than 3 months
9) adequate interval after prior treatments; 2 weeks from radiotherapy, 8 weeks from lobectomy, 4 weeks from exploratory thoracotomy, 2 weeks pleural drainage
10) written informed consent
Key exclusion criteria
1) brain metastasis
2) histroy of hemoptysis
3) serious complication; cardiac disea
se, interstitial peumonia, diabetes, active infection
4) massive pleural or pericardial effusion, ascites
5) concomitant malignancy
6) uncontrollable peptic ulcer or GI perforaion within 1 year
7) uncontrollable hypertension
8) anticoagulation therapy
9) inappropriate for this study judged by the attending physician
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ogura |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
Address
Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan
TEL
045-701-9581
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Terufumi Kato |
Organization
Kanagawa Cardiovascular and Respiratory Center
Division name
Department of Respiratory Medicine
Zip code
Address
Tomioka-higashi 6-16-1, Kanazawa-ku, Yokohama, Japan
TEL
045-701-9581
Homepage URL
http://www.torg.or.jp/
t-kato@kanagawa-junko.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
Thoracic Oncology Research Group
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
| 2010 | Year | 10 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | 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
| 2010 | Year | 10 | Month | 11 | Day |
Last modified on
| 2013 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005222
