UMIN-CTR Clinical Trial

Basic information
Public title	Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer
Acronym	Phase 2 study of CBDCA and weekly nab-PTX for elderly squamous cell lung cancer
Scientific Title	Phase 2 study of carboplatin and weekly nab-paclitaxel for elderly squamous cell lung cancer
Scientific Title:Acronym	Phase 2 study of CBDCA and weekly nab-PTX for elderly squamous cell lung cancer
Region	Japan

Condition
Condition	squamous cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate for efficacy and toxicities of CBDCA and weekly nab-PTX for elderly(more than 75 years-old) squamous cell lung cancer
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	overall survival,response rate,toxicities,disease control rate

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	CBDCA at the dose of area under curve 5 (day1) and nab-PTX at the dose of 100mg/m2(day1.8.15)every 3 weeks ,up to 6 cycles.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Definitively diagnosed with having squamous cell lung cancer by the specimens histologically or cytologically. 2)Clinical Stage 3B which curative radiotherapy is not indicated,4 or postoperative recurrence. 3)No prior chemotherapy. *Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted. 4)No prior radiotherapy for primary lesions.(Palliative local radiation except for primary lesion is permitted.) 5)At least one measurable lesion. 6)Age of 75 year or older. 7)ECOG Performance status of 0-1. 8)Sufficient major organ function as below *Neutrophil count>=1500/mm3 *Platelet count>=100000/mm3 *Hemoglobin>=9.0g/dl *total bilirubin<=1.5mg/dl *AST<=ULNX2.5 *ALT<=ULNX2.5 *Serum creatinine<=1.5mg/dl *PaO2>=60 Torr or more(or SpO2 >=95% or more) 9)Life expectancy of at least 3months 10)Written informed consent
Key exclusion criteria	1)With active other organ cancer 2)With active infection 3)With fever equal to or more than 38C 4)With mental disorder 5)With symptomatic brain metastasis 6)Pleural and peritoneal effusion likely to require surgical intervention,or pericardial effusion 7) Systematic steroids , immunosuppressive medication or poorly controlled diabetes 8)Grade 2 or higher peripheral neuropathy 9)Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 10)poorly controlled hypertension 11)Ischemic heart disease or cardiac infarction within 6 months before enrollment 12)History of severe drug allergies 13)Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Kudoh,Sinzoh Middle name Last name Kudoh,Sinzoh
Organization	Osaka City University Hospital
Division name	Department of Pulmonary Medicine
Zip code	5458586
Address	1-5-7 Asahi-machi,Abeno-ku,Osaka-shi,545-8586,Osaka,Japan
TEL	06-6645-2121
Email	shinzohykudoh@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Katsushima,Utae Middle name Last name Katsushima,Utae
Organization	Osaka City General Hospital
Division name	Department of clinical oncology
Zip code	5340021
Address	x9i \[/
TEL	06-6929-1221
Homepage URL
Email	u_sota123@yahoo.co.jp

Sponsor
Institute	Osaka City General Hospital
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	Osaka City General Hospital
Address	2-13-22,Hondori,Miyakojima,Miyakojima-ku,Osaka-shi,534-0021,Osaka,Japan
Tel	06-6929-1221
Email	u_sota123@yahoo.co.jp

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	大阪市立大学 大阪市立総合医療センター 近畿中央胸部疾患センター 淀川キリスト病院 ベルランド総合病院 JR大阪鉄道病院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 11 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	2013 Year 09 Month 26 Day
Date of IRB	2013 Year 09 Month 26 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2016 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2013 Year 10 Month 11 Day
Last modified on	2019 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014005