UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006767 |
|---|---|
| Receipt number | R000007991 |
| Scientific Title | Phase II study of Carboplatin, Paclitaxel and Bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer with large malignant pleural effusion. |
| Date of disclosure of the study information | 2011/11/30 |
| Last modified on | 2012/12/14 23:37:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II study of Carboplatin, Paclitaxel and Bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer with large malignant pleural effusion.
Acronym
Phase II study of Carboplatin, Paclitaxel and Bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer with large malignant pleural effusion.
Scientific Title
Phase II study of Carboplatin, Paclitaxel and Bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer with large malignant pleural effusion.
Scientific Title:Acronym
Phase II study of Carboplatin, Paclitaxel and Bevacizumab in patients with advanced Non-squamous non-small-cell lung cancer with large malignant pleural effusion.
Region
| Japan |
Condition
Condition
Non-squamous non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, safety and QOL of the combiation chemotherapy of carboplatin, paclitaxel and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer with large malignant pleural effusion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
4-week PPFS rate (Pleural progression-free survival (PPFS) was defined as the time from randomization to the first observation of pleural progression or death due to any cause.)
Key secondary outcomes
Ovrall survival, Progression free survival, Response rate, Time to pleural progression, Safety, Quality of life
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
Carboplatin + Paclitaxel + 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 confirmed non-squamous non-small-cell lung cancer
2) Clinical stage IV or post-operative recurrence
3) Pathologically proven large pleural effusion associated with non-small-cell lung cancer
4) Chemotherapy naive except for EGFR-TKI
5) Age over 20 years old with performance status 0-1
6) No prior pleurodesis
7) No prior thoracotomy nor thoracic radiation within 4 weeks
8) Adequate organ funcions
9) Signed informed consent
Key exclusion criteria
1) Actuve concomitant malignancy
2) Massive pericardial effusion
3) With rain metastasis, or tumor with large vessel invasion or cavity formation
4) Episode of hemoptysis
5) Those judged to be not suitable by the attending physician
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tateaki Naito |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777
TEL
055-989-5222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Madoka Kimura |
Organization
Shizuoka Cancer Center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777
TEL
Homepage URL
Sponsor or person
Institute
Shizuoka Cancer 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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 30 | 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
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
| 2011 | Year | 11 | Month | 24 | Day |
Last modified on
| 2012 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007991
