UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006759 |
|---|---|
| Receipt number | R000007992 |
| Scientific Title | Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer |
| Date of disclosure of the study information | 2011/11/24 |
| Last modified on | 2018/05/28 17:03:27 |
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Basic information
Public title
Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Acronym
Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Scientific Title
Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Scientific Title:Acronym
Phase II Study of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with non-squemous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Non-squamous,non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of neoadjuvant chemotherapy with carboplatin,pemetrexed and bevacizumab in patients with inoperable non-squemous non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Down staging rate
Key secondary outcomes
2year survival rate,2-years relapse free survival,Progression free survival,rate of completion of the protocol treatment,Pathologic complete response rate,Complete resection rate,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
CBDCA AUC6(day1)+Pemetrexed 500mg/m2(day1)+Bevacizumab 15mg/kg(day1)
q3weeks x2cycles
CBDCA AUC6(day1)+
Pemetrexed 500mg/m2 (day1)
q3weeks x1cycles
Surgical operation is performed over 3 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 cytologically proven non-squamous non small cell lung cancer
2)Patients with StageII(exclusing N0)/III
3)Without previously treatment for lung cancer
4)ECOG Performance status 0-1
5)Age:20 years to less than 75 years
6)Patients who has measurable by RECIST(ver 1.1)criteria
7)Adequate organ function
8)Life expectancy more than 3 months
9)Signed written informed consent
Key exclusion criteria
1)Uncontrolled infection or Serious medical complications
2)Uncontrollable diabetes mellitus
3)Uncontrollable hypertension
4)Therapeutic anticoagulopathy (except Aspirin within 325mg/day)
5)Current or previous history of hemoptysis
6)Evidence of bleeding diathesis or hemoptysis
7)With great vessel invasion
8)Cavity in tumor
9)Uncontrollable gastrointestinal ulceration
10)Current or previous(within the last 1 year) history of GI perforration
11)History of severe heart disease
12)Interstitial pneumonia or pulmonary fibrosis detectableon chest X-ray
13)Multiple primary cancer
14)With a history of drug sensitivity
15)Patients who do not want to take vitamin preparation
16)Serious psychiatric illness or psychological symptom
17)Women who are pregnant, lactating or with childbearing potential
18)Ineligible based on decision of an investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Sato |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Department of Thoracic Surgery
Zip code
Address
1-1-1 Tennodai,Tsukuba 305-8575, Japan
TEL
029-853-3097
ysato@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Sato |
Organization
University of Tsukuba
Division name
Faculty of Medicine, Department of Thoracic Surgery
Zip code
Address
1-1-1 Tennodai,Tsukuba 305-8575 Japan
TEL
029-853-3097
Homepage URL
ysato@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba, Faculty of Medicine, Department of Thoracic Surgery
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 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 11 | Month | 22 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007992
