UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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).
Title of the study (Brief title)	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	Takafumi Suda
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal medicine, second division.
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	Masato Karayama
Organization	Hamamatsu Univ. School of Medicine
Division name	Department of Internal medicine, second division.
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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