UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005917 |
|---|---|
| Receipt number | R000006997 |
| Scientific Title | Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer |
| Date of disclosure of the study information | 2011/07/04 |
| Last modified on | 2016/05/11 15:43:28 |
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Basic information
Public title
Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer
Acronym
Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive NSCLC
Scientific Title
Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer
Scientific Title:Acronym
Feasibility study of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive NSCLC
Region
| Japan |
Condition
Condition
Stage IV EGFR mutation positive non-small-cell lung cancer patients
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Pemetrexed/Cisplatin/Bevacizumab and EGFR-TKIs in alternating cycles followed by Pemetrexed/Bevacizumab and EGFR-TKIs in alternating cycles as maintenance therapy for patients with stage IV EGFR mutation positive non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment completion rate of induction therapy
Key secondary outcomes
Response Rate
Disease Controle Rate
Pprogression-Free-Survival
1-year Survival Rate
Safety
Overall Survival
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
Pemetrexed/Cisplatin/Bevcizumab+EGFR-TKIs followed by Pemetrexed/Bevacizumab+EGFR-TKIs until progression disease
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)EGFR mutations in the tumor specimens
2)Stage IV non-small cell lung cancer proven by histology
3)No prior chemotherapy
4)Tumors that could be measurable by RECIST
5)Age 20 to 75 years
6)ECOG performance status of 0-1
7)No severe impairment of major organs, laboratory data within 14 days
Neutrophil ≥ 2,000/mm3
Platelet ≥ 100,000/mm3
Hemoglobin ≥ 9.0 g/dl
AST and ALT ≥ 2.5 ULN
T-Bil ≥ 1.5 ULN
Albumin ≥ 2.5 g/dl
Cre ≥ 1.5 mg/dl
Cr ≥ 45 ml/min
SpO2(Room air) ≥ 92%
8)A life expectancy of more than 90 days
9)Written informed consent
Key exclusion criteria
1)Squamous Cell Carcinoma
2)Interstitial pneumonia or pulmonary fibrosis on Chest Xray
3)Superior vena cava syndrome
4)Renal dysfunction
5)Patients with superior vena cava syndrome
6)Central nervous system metastases
7)Other active malignancy
8)Uncontrollable hypertension, uncontrollable diabetes
9)Patients who are diagnosed as cirrhosis with image orclinical examination
10)Heart disease as follows; unstable angina, myocardial infarction within 6 months, post-PTCA or post-CAGB, congestive heart failure, arrhythmia requiring treatment
11)Pregnancy, lactation or no intention to practice birth control
12)Sever drug allergy
13)Acute inflammatory disease
14)No consent to blood transfusion or other supportive care
15)With a clinical bleeding tendency
16)History of sever hemoptysis or bloody sputum
17)Cavity lesion
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Iwasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
Address
465 Kajii-cho, Kamigyoku, Kyoto city 602-8566
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Iwasaki |
Organization
Kyoto Prefectural University of Medicine
Division name
Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
yiwasaki@kyoto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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 | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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 | 07 | Month | 04 | Day |
Last modified on
| 2016 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006997
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