UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008771 |
|---|---|
| Receipt number | R000010308 |
| Scientific Title | Phase II study of pemetrexed or pemetrexed plus bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2012/08/27 |
| Last modified on | 2021/02/15 10:55:11 |
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Basic information
Public title
Phase II study of pemetrexed or pemetrexed plus bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer
Acronym
Phase II trial of PEM or PEM/BEV
Scientific Title
Phase II study of pemetrexed or pemetrexed plus bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer
Scientific Title:Acronym
Phase II trial of PEM or PEM/BEV
Region
| Japan |
Condition
Condition
Previously untreated elderly non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine efficacy and safety of pemetrexed or pemetrexed/bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer and the regimen for phase III study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response, Overall survival, Adverse effect, Cost effectiveness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed
Interventions/Control_2
Pemetrexed plus bevacizumab
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) histologically confirmed diagnosis of NSqNSCLC; 2) no prior chemotherapy or molecular targeted therapy
3) stage IIIB or IV with no indication of radical radiotherapy, or recurrence after operation
4) no active overlapping cancer
5) age >=75 years
6) Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
7) adequate organ function (leukocyte count >=4,000/mm3, hemoglobin level >=9 g/dl, platelet count >=100,000/mm3, ALT and AST levels <100 IU/L,serum bilirubin level =<1.5 mg/dl,serum creatinine level=<1.5 mg/dl,proteinurea =<1+ and PaO2 >=60 Torr (or SpO2 >=90)
8) evaluable lesion
9) informed consent
10) life expectancy greater than 3 months
Key exclusion criteria
1) symptomatic brain metastasis
2) complications as follows: hemoptysis, arterial and venous thromboembolism, uncontrolled hypertension, perforation of the digestive tract/severe fistula/bronchoesophageal fistula, inflammation in abdominal cavity, congenital bleeding predisponency/abnormality of hemostasis, uncontrolled diabetes
3) operation within 28 days
4) planning of thoracic radiotherapy in bevacizumab therapy
5) symptomatic pericardial effusion
6) symptomatic SVC syndrome
7) interstitial pneumonia confirmed in chest X-ray
8) psychotic disease judged should not to participate the trial
9) other inadequacy cases judged by attending physician
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukito Ichinose |
Organization
National Kyusyu Cancer Center
Division name
Clinical Research Center
Zip code
Address
3-1-1 Nodame, South, Fukuoka, ZIP811-1395, Japan
TEL
092-541-3231
yichinos@nk-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Fukuda |
Organization
Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Department of Respiratory Diesease
Zip code
Address
3-15 Mori, Nagasaki, 852-8511, Japan
TEL
095-847-1511
Homepage URL
mifukuda258@nifty.com
Sponsor or person
Institute
Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
| 2012 | Year | 08 | Month | 27 | 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
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 26 | Day |
Last modified on
| 2021 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010308
