UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014302 |
|---|---|
| Receipt number | R000016652 |
| Scientific Title | Phase II study comparing combination therapy with carboplatin plus pemetrexed vs combination therapy with pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous non-small-cell lung cancer (HSR1402). |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2018/10/04 15:06:25 |
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Basic information
Public title
Phase II study comparing combination therapy with carboplatin plus pemetrexed vs combination therapy with pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous non-small-cell lung cancer (HSR1402).
Acronym
Carboplatin plus pemetrexed vs pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous non-small-cell lung cancer.
Scientific Title
Phase II study comparing combination therapy with carboplatin plus pemetrexed vs combination therapy with pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous non-small-cell lung cancer (HSR1402).
Scientific Title:Acronym
Carboplatin plus pemetrexed vs pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous non-small-cell lung cancer.
Region
| Japan |
Condition
Condition
advanced non-squamous non-small-cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of combination therapy with carboplatin plus pemetrexed and pemetrexed plus bevacizumab in chemo-naive elderly patients with advanced non-squamous 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
progression-free survival
Key secondary outcomes
objective response rate, overall survival, safety, quality of life(QoL)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Carboplatin AUC5+pemetrexed 500mg/m2, day1, 21-day cycle, four cycles. After four cycles of the therapy, patients who achieved more than stable disease receive maintenance therapy with pemetrexed 500mg/m2, Day1, 21-day cycle until progressive disease or unacceptable adverse events occur.
Interventions/Control_2
Pemetrexed 500mg/m2+bevacizumab 15mg/kg, day1, 21-day cycle until progressive disease or unacceptable adverse events occur.
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
| 76 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. pathologically or cytologically diagnosed non-squamous non-small-cell lung cancer.
2. measurable disease in RECIST.
3. ECOG PS of 0-1
4. Stage IIIB without indication of curative radiotherapy, stage IV disease or recurrence disease without prior adjuvant chemotherapy.
5. Aged 76 years or older.
6. adequate organ function.
Neutrophil cout of more than 2000/uL
Platelet cout of more than 100000/uL
Hemoglobin level of more than 9.0 g/dL
Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range.
Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
PaO2 of more than 60 torr or SpO2 of more than 90%.
Serum creatinine of less than 1.2mg/dL or creatinine clearance of less than 45mL/min.
Protein urea less than plus 1 in urine test.
7: Life expectancy of more than 3 months.
8: Written informed consent.
Key exclusion criteria
1. squamous histology
2. interstitial lung disease or pulmonary fibrosis
3. presence or history of hemoptysis
4. pleural effusion or cardiac effusion that needs to be treated
5. superior vena cava syndrome
6. uncontrolled and symptomatic brain metastasis except stable brain metastases after radiotherapy
7. uncontrolled diabetes, hypertension, liver damage, ischemic heart disease or myocardial infarction within three months.
8. severe infectious disease
9 pregnancy, lactation, or willing to get pregnant.
10. active malignancy of other organ.
11.history of severe hypersensitivity to drugs
12. bleeding diathesis or coagulopathy
13. symptomatic cerebrovascular disease, or history of brain attack 12 months prior to the study.
14. uncontrolled digestive ulcer or history of gastrointestinal perforation.
15. other severe comorbidities
16. judgement of discontinuation by attending physicians
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Suda |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal medicine, second division.
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Karayama |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of Internal medicine, second division.
Zip code
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
053-435-2263
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Univ. School of Medicine
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
聖隷三方原病院, 国立病院機構天竜病院, 浜松赤十字病院
浜松労災病院, 遠州病院, 磐田市立総合病院, 静岡県立総合病院
静岡市立静岡病院, 静岡市立清水病院, 藤枝市立総合病院
浜松医療センター, 静岡赤十字病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 19 | 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
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016652
