UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008817 |
|---|---|
| Receipt number | R000010364 |
| Scientific Title | A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2014/09/10 17:04:52 |
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Basic information
Public title
A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Acronym
A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Scientific Title
A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Scientific Title:Acronym
A Study on the efficacy of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-Squamous Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant chemotherapy with carboplatin, docetaxel and bevacizumab in patients with non-squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Pathological complete resection rate
Key secondary outcomes
Pathological response rate (pRR)
Complete resection rate
Relapse-free survival (RFS)
Overall survival (OS)
Safety
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 | Maneuver |
Interventions/Control_1
Carboplatin + Docetaxel + Bevacizumab
day1 q3w 2cycles
Surgical operation is performed over 5 weeks after protocol 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) Histologically or pathologically confirmed non-squamous non-small cell lung cancer
2) Clinical stage IB- IIIA
3) Age:20-74years old
4) ECOG PS 0-1
5) Patients without previous treatment for lung cancer
6) If the patient underwent therapy, there should be the following interval between the therapy and the registration
-Open biopsy,Treatment of injury->2 weeks
-Aspiration biopsy,->1 week
7) Sufficient organ function
8) Written IC
Key exclusion criteria
1) History of severe drug allergy
2) Patients with uncontrollable complications
3) Patients with symptomatic Brain metastasis
4) History of hemoptysis ( >= 2.5mL)
5) History of continuous hemosputum
6) Patients with massive pleural and cardiac effusion
7) Patients with uncontrollable peptic ulcer
8) History of myocardial infarction or cerebral infarction
9) Current or previous history of GI perforation
10) Patients with therapeutic anticoagulopathy
11) Pregnancy, breast feeding and suspected pregnancy
12) Active concomitant malignancy
13) Inappropriate patients for this study judged by the physicians
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiko Furuichi |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of respiratory surgery
Zip code
Address
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
TEL
03-3972-8111
furuichi.motohiko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohiko Furuichi |
Organization
Nihon University School of Medicine Itabashi Hospital
Division name
Department of respiratory surgery
Zip code
Address
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
furuichi.motohiko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine Itabashi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine Itabashi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawaguchi Municipal Medical Center
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
| 2012 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2014 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010364
