UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009032 |
|---|---|
| Receipt number | R000010598 |
| Scientific Title | PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer |
| Date of disclosure of the study information | 2012/10/03 |
| Last modified on | 2018/04/08 18:53:40 |
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Basic information
Public title
PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Acronym
PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Scientific Title
PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Scientific Title:Acronym
PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Region
| Japan |
Condition
Condition
Non-Squamouns Non-small-cell-lung-cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
PhaseII Study of Neoadjuvant and adjuvant Chemotherapy with Pemetrexed/Carboplatin/Bevacizumab in patients with non-squamouns non Small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Treatment completion rate of the protocol Treatment
Key secondary outcomes
Response Rate
Disease Free Survival
Overall Survival
Rate of Serious adverse events
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 |
Interventions/Control_1
PEM 500 mg/m2 as preoperative therapy to aid Day1 under folic acid and VB12, administered, BEV 15mg/kg CBDCA AUC5, 3 weeks*2 cycles. However, the third course, two-drug combination of CBDCA and PEM.
For patients over SD is carried out every two week course 3 PEM 500 mg/m2 as adjuvant therapy, the CBDCA AUC5 at preoperative 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>preoperative therapy
(1)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC)
(2)Stage IB/II/IIIA(UICC-7) NSCLC
(3)Age:20 years
(4)ECOG performance status of 0 or 1
(5)Normal organ function WBC>4,000/mm-3
neutro > 2,000/mm-3, Plt > 100,000/mm-3, Hb > 9.5 g/dL-1, AST(GOT), ALT(GPT)< 3.0x upper normal limit, T-Bil< 1.5x upper normal limit, creatinine clearance > 60 ml/min
(6)Written informed consent
>postoperative therapy
(1)Non-PD after 3 cycles of induction Chemotherapy
(2)Restore organ function
(a)WBC > 4,000/mm-3
(b)neutro > 2,000/mm-3, Plt > 100,000/mm-3, Hb > 9.5 g/dL-1, AST(GOT), ALT(GPT)< 3.0x upper normal limit, T-Bil< 1.5x upper normal limit, creatinine clearance > 60 ml/min
Key exclusion criteria
>preoperative therapy
(1) severe comorbit disease
(2) history of hemoptysis, coagulation disorder and thrombosis or receive oral/i.v. hemostatic drug
(3) With a clinical bleeding tendency
(4) tumor cavitation and invasion to the major vessel
(5) Patients of Untreated fracture (Such as compression fractures due to osteoporosis are excluded) or High degree of wound
(7)Patients of the merger of infections requiring intravenous administration of anti-viral agents or anti-fungal agents,antibiotics
(8) Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day)
(9) Patients with uncontrollable gastrointestinal ulceration
(10) Patients with current or previous (within one year) history of gastrointestinal perforation
(11) Patients with Symptomatic congestive heart failure,Unstable angina,Arrhythmia with treatment. Patients With a history of myocardial infarction within one year prior to registration.
(12)In patients with persistent diarrhea. (There is a watery stool more than three times a day at the time of registration)
(13) Patients with previous histories of drug allergy
(14)history of drug induced interstitial pneumonia
(15)regnant or lactating women or those who declined contraception
(16)those judged to be not suitable by the attending physician
>postoperative therapy
(1) It is found that you have been registered in violation of the selection criteria or exclusion criteria
(2) Apparent worsening of the disease due to cancer was observed
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKASHI YOKOI |
Organization
Kansai Medical University Hirakata Hospital
Division name
respiratory medicine
Zip code
Address
2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL
072-804-0101
yokoit@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKASHI YOKOI |
Organization
Kansai Medical University Hirakata Hospital
Division name
respiratory medicine
Zip code
Address
2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL
0728040806
Homepage URL
yokoit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 03 | 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 | 10 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010598
