UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007129 |
|---|---|
| Receipt number | R000008397 |
| Scientific Title | PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) Non-squamous Non-Small-Cell Lung Cancer |
| Date of disclosure of the study information | 2012/01/24 |
| Last modified on | 2023/02/01 14:10:42 |
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Basic information
Public title
PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) Non-squamous Non-Small-Cell Lung Cancer
Acronym
PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) Non-squamous Non-Small-Cell Lung Cancer
Scientific Title
PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) Non-squamous Non-Small-Cell Lung Cancer
Scientific Title:Acronym
PhaseI/II Study of neoadjuvant therapy with Carboplatin Paclitaxel plus Bevacizumab for stage II/IIIA(>T2) 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 efficacy and safety of neoadjuvant therapy with Carboplatin,Paclitaxel plus Bevacizumab for stage II/IIIA Non-squamous Non-Small-Cell Lung Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
STEP1
Safety
STEP2
Overall Response Rate
Key secondary outcomes
Pathological Complete Response Rate
Complete Resection Rate
Relapse Free Survival Rate(1year,2years)
Overall Survival Rate(1year,2years)
Adverse events
Blood loss during Oparation /Operation Time
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
1)CBDCA (AUC6 day1) + Paclitaxel(200mg/m2 day1) + Bevacizumb (15mg/kg day1) q3weeks 2 cycles
2)CBDCA (AUC6 day1) + Paclitaxel(200mg/m2 day1) q3weeks 1cycle
3) Surgery
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 cytologically confirmed non-squamous non-small cell lung cancer(NSCLC)
2) Age:20-74years old
3) ECOG PS: 0 or 1
4) Without prior anti-cancer therapy (Surgery,radiation and chemotherapy therapy )
5) Patients with stage II/IIIA(>T2)
6) Operable patient
7) Adequate organ function
8) Written informed consent from the patient
Key exclusion criteria
1) Pleural effusion, pericardial effusion and ascites to need treatment
2) Current or previous histoty of hemoptysis (2.5ml) due to NSCLC
3) Evidence of bleeding diathesis or hemoptysis
4) With great vessel invasion
5) Cavity in tumor
6) Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day)
7) Active concomitant malignancy
8) Severe complications
a)Current or previous history of cerebrovascular disease
b)Current or previous history of GI perforation
c)Severe cardiac disease
d)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis
e)Traumatic fracture of unrecovery
f) Uncontrollable peptic ulcer
g)Uncontrollable hypertenson
h)Uncontrollable infectious disease
9) History of severe allergic reaction with platinum drug ,chemotherapy drug or monoclonal antibody
10) Pregnant or breast-feeding females
11) Decision of ineligibility by a physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
4313192
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
4313192
Address
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
TEL
053435-2276
Homepage URL
https://www.hama-med.ac.jp/hos/departments/thoracic-surg/study.html
kfunai@hama-med.ac.jp
Sponsor or person
Institute
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
Institute
Department
Personal name
kazuhito Funai
Funding Source
Organization
Hamamatsu University School of Medicine, First Department of Surgery
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
Hamamatsu University School of Medicine,
Address
1-20-1, handa-yama, Higashi-ku, hamamaysu
Tel
053-435-2680
rinri@hama-med.ac.jp
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
浜松医科大学 第一外科（静岡県）
聖隷三方原病院 呼吸器外科（静岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 24 | 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 | 06 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | 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
| 2012 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008397
