UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Acronym	A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Scientific Title	A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Scientific Title:Acronym	A Phase II study of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer (OSAKA-LCSG1302)
Region	Japan

Condition
Condition	Chemo-naive patients with squamous cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy and safety of q4w carboplatin plus nab-paclitaxel in chemo-naive patients with squamous cell lung cancer
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	Progression-free survival (PFS), PFS in cases given maintenance therapy, Overall survival (OS), Maintenance extraction rates, Frequency and grade of adverse event

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-PTX 100mg/m2 (day1, 8, 15) + Carboplatin (AUC = 6, day 1) q4weeks 4cycles followed by nab-PTX 100mg/m2 (day1, 8, 15) q4weeks until disease progression
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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytologically confirmed squamous cell lung cancer 2.Stage III/IV without any indications for radiotherapy, or recurrent disease after surgery 3.chemo-naive 4.If 12 months or more pass, the adjuvant chemotherapy is not assumed to be a previous chemotherapy 5.The picibanil used by the pleurodesis is assumed to be registrable 6.EGFR, ALK, and MET inhibitor mono-therapy does not mean previous chemotherapy 7.The patients have not been conducted radiation therapy (Except for applied palliative radiation for the primary tumor) 8.Measurable disease 9.Age 20-74 10.ECOG performance status of 0 to 1 11.Adequate organ function, evaluated within 14 days before enrollment as; Neu >= 1,500 /mm3 Plt >= 100,000 /mm3 hemoglobin >= 9.0 g/dL ALT (GPT) =< 100 IU/L T. bil =< 1.5 mg/dL Cr >= 1.5mg/dL SpO2 >= 95% or >= 60 torr 12.Expected to live over 3 months after administration days 13.Written informed consent from the patients
Key exclusion criteria	1.Adjuvant chemotherapy of PTX 2.Active synchronous malignancy 3.Symptomatic brain metastasis 4.Patients with pleural effusion, ascites and/or pericardial effusion requiring drainage 5.>= G2 peripheral neuropathy 6.Pneumonia or Pulmonary fibrosis detectable on chest X-rays. 7.serious complication ischemic heart disease, cardiac arrhythmia, post-MI, hepatic cirrhosis, gastrointestinal ulcer, DM 8.History of severe drug allergy 9.Women with a possibility of pregnancy, pregnant or lactating 10.Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	2-15 Yamada-oka, Suita, Osaka, Japan
TEL	06-6879-3833
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Kijima
Organization	Osaka University Hospital
Division name	Dept. of Respiratory Medicine
Zip code
Address	2-15 Yamada-oka, Suita, Osaka
TEL	06-6879-3833
Homepage URL
Email	tkijima@imed3.med.osaka-u.ac.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)

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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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 08 Month 09 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 09 Month 27 Day
Last modified on	2017 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013892

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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