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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014302
Receipt No. 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

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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
Email 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
Email karayama@hama-med.ac.jp

Sponsor
Institute Hamamatsu Univ. School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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