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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004487
Receipt No. R000005363
Scientific Title Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IIIA Non-Squamous Non-Small Cell Lung Cancer
Date of disclosure of the study information 2010/11/01
Last modified on 2017/11/12

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Basic information
Public title Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IIIA Non-Squamous Non-Small Cell Lung Cancer
Acronym Phase II Trial of Preoperative Chemotherapy and Bevacizumab
Scientific Title Phase II Trial of Preoperative Chemotherapy and Bevacizumab in Patients With Stage IIIA Non-Squamous Non-Small Cell Lung Cancer
Scientific Title:Acronym Phase II Trial of Preoperative Chemotherapy and Bevacizumab
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 assess 3-year disease-free survival in patients with stage IIIA NSCLC treated with preoperative carboplatin, paclitaxel, and bevacizumab followed by surgical resection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 3-year disease free survival
Key secondary outcomes Rate of completion of the protocol treatment
Overall survival
Disease-free survival
clinical and pathologic response
Complete resection rate
Toxicity
Intraoperative and postoperative complications

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 CBDCA AUC=5 (Day1)
Paclitaxel 200mg/m2 (Day1)
Bevacizumab 15mg/kg (Day0 or1)
and 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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven non-squamous non-small cell lung cancer
2) Patients with resectable stage IIIA (UICC-7th edition)
3) Without previously treatment for lung cancer
4) Age:20-74
5) PS:0-1
6) Expected FEV 1.0 > 1.0L after lung resection
7) Adequate organ function
8) Written informed consent
Key exclusion criteria 1) Active double cancer
2) Current history of hemoptysis
3) Evidence of bleeding diathesis or coagulopathy
4) With great vessel invasion
5) Cavity in tumor
6) History of uncontrollable pericardial effusion
7) History of severe heart disease
8) Current or previous history (within the last 1 year) of symptomatic cerebrovascular disease
9) Active infectious disease in need of intravenous administration of anti-bacterial, anti-fungal, or anti-viral drugs
10) Receiving anticoagulant drug (except Aspirin within 324 mg/day)
11) Uncontrollable Gastrointestinal ulceration
12) Current or previous(within the last 1 year)history of GI perforation
13) Uncontrollable systemic disease (hyper tension or diabetes mellitus)
14) Interstitial pneumonia or pulmonary fibrosis detectable on chest Xp
15) Peripheral neuropathy > Grade2
16) With a history of drug sensitivity
17) History of pregnancy or lactation
18) No intention to practice birth control
19) Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masahiko Higashiyama
Organization Osaka International Cancer Institute
Division name General thoracic surgery
Zip code
Address 3-1-69 Otemae Chuouku, Osaka
TEL 06-6945-1181
Email okami-ji@mc.pref.osaka.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Jiro Okami
Organization Osaka International Cancer Institute
Division name General thoracic surgery
Zip code
Address 3-1-69 Otemae Chuouku, Osaka
TEL 06-6945-1181
Homepage URL
Email okami-ji@mc.pref.osaka.jp

Sponsor
Institute Osaka International Cancer Institute
Institute
Department

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
Email

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 11 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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 11 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
2010 Year 11 Month 01 Day
Last modified on
2017 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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