UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004487 |
|---|---|
| Receipt number | 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 16:05:27 |
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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
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
okami-ji@mc.pref.osaka.jp
Public contact
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
okami-ji@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005363
