UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer using MNA
Title of the study (Brief title)	OSAKA-LCSG1305
Region	Japan

Condition
Condition	Squamous cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Carboplatin plus nab-paclitaxel in elderly patients with squamous cell lung cancer using MNA.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Overall survival, Progression free survival, Disease control rate, SPARC expression and safety.

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 100mg/m2 on days 1, 8, 15 + Carboplatin AUC 6 on day 1 every 4 weeks.
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed squamous cell lung cancer. 2) Clinical Stage III which curative radiotherapy is not indicated, IV or postoperative recurrence 3) MNA-SF score >= 8 4) No prior chemotherapy *Adjuvant chemotherapy finished before 6 months or more from enrollment is permitted. 5) No prior radiotherapy for primary lesions. (Palliative local radiation except for primary lesion is permitted.) 6) At least one measurable lesion 7) Age of 70 years or older 8) ECOG Performance status of 0-1 9) Sufficient major organ function as bellow *Neutrophil count >= 1,500 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.0 g/dL *total bilirubin <= 1.5 mg/dL *AST/ALT <= ULN*2.5 *Serum creatinine <= 1.5 mg/dL *PaO2 >= 60 Torr or more (or SpO2 >= 95% or more) 10) Life expectancy of at least 3 months 11) Written informed consent
Key exclusion criteria	1) Previous treatment with paclitaxel as adjuvant chemotherapy 2) Active double cancer 3) Symptomatic brain metastasis 4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion 5) Grade 2 or higher peripheral neuropathy 6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 7) Severe concurrent disease (Ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hepatic failure, hemorrhagic peptic ulcer, poorly controlled diabetes) 8) History of Severe drug allergies. 9) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 10) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Kijima
Organization	Osaka University Hospital
Division name	Department of Respiratory Medicine
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3831
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Takayuki Shiroyama
Organization	Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Division name	Department of Thoracic Malignancy
Address	3-7-1 Habikino Habikino city Osaka
TEL	072-957-2121
Homepage URL
Email	takayuki.s12@hotmail.co.jp

Sponsor
Institute	OSAKA-LCSG
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 17 Day
Anticipated trial start date	2013 Year 10 Month 17 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	2013 Year 10 Month 16 Day
Last modified on	2017 Year 04 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013161