UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Title of the study (Brief title)	Phase II study of nab-paclitaxel and carboplatin for elderly patients with non-small cell lung cancer. (KRSG1303)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We evaluate efficacy and safety of nab-paclitaxel and carboplatin for elderly (more than 75 years-old) patients with untreated non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Disease control rate, Frequent of adverse event, Progression free survival, Overall Survival, Rate of secondary treatment

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	Nab-paclitaxel is administered 100 mg/m2 on day 1, 8, 15 every 3 weeks, Carboplatin is administered AUC5 on day 1 every 3weeks.
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) Histologically or cytologically confirmed Clinical Stage IIIB, IV or postoperative recurrence 2) Age of more than 75 years-old 3) Not with active other organ cancer 4) With one or more measurable lesion 5) No prior chemotherapy Adjuvant chemotherapy finished before 4 weeks or more in case of UFT, 12 months or more in case of other chemotherapy from enrollment is permitted. 6) With adequate organ function of bone marrow reserve, liver, and kidney. Sufficient major organ function as bellow Neutrophil count => 1,500 /mm3 Platelet count => 100,000 /mm3 Hemoglobin => 9.0 g/dL AST(GOT)/ALT(GPT) <= 2.5 times less than ULN total bilirubin <= 1.5 mg/dL Serum creatinine <= 1.5 mg/dL ECG: without clinically problematic abnorbomalities Peripheral neuropathy <= Grade 1 7) Life expectancy of at least 3 months 8) ECOG Performance status of 0-1 9) Written informed consent
Key exclusion criteria	1) Patients with Symptomatic brain metastasis 2) Patients have only non-measurable lesion 3) Patients with radiotherapy for cancer within 4 weeks 4) Patients with interstitial pneumonia 5) Patients with Serious complications (renal dysfunction, liver dysfunction, cardiac diseases, uncontrolled hypertension or diabetes) 6) Patients with other Serious complications 7) Judged ineligible based on physicians' decision
Target sample size	32

Research contact person
Name of lead principal investigator	Shinichiro Koyama
Organization	Jichi Medical University Saitama Medical Center
Division name	Division of Pulmonary Medicine, Clinical Department of Internal Medicine
Address	1-847 Amanuma-cho, Omiya-ku, Saitama-shi, 330-8503, Saitama, Japan
TEL	048-647-2111
Email	skoyama@omiya.jichi.ac.jp

Public contact
Name of contact person	Nobuyuki Koyama
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Clinical Oncology
Address	1163 Tatenachi, Hachioji-shi, Tokyo, 193-0998, Japan
TEL	042-665-5611
Homepage URL
Email	nkoyama@tokyo-med.ac.jp

Sponsor
Institute	Kanto respiratory disease study group
Institute
Department

Funding Source
Organization	Kanto respiratory disease study group
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	埼玉県立循環器呼吸器病センター 防衛医科大学校 さいたま市立病院 埼玉医科大学呼吸器病センター 埼玉医科大学国際医療センター 足利赤十字病院 さいたま赤十字病院 独法東埼玉病院 独法西群馬病院 深谷赤十字病院 栃木県立がんセンター 埼玉医科大学総合医療センター 自治医科大学付属病院 済生会宇都宮病院 前橋赤十字病院 自治医科大学附属さいたま医療センター 獨協医科大学越谷病院 東京医科大学八王子医療センター 東京医科大学茨城医療センター

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 04 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This trial stopped because the targeted number of cases cannot be achieved.
Other related information

Management information
Registered date	2013 Year 08 Month 20 Day
Last modified on	2019 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013471