UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II study of nab-Paclitaxel (nab-PTX) plus Carboplatin(CBDCA) followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.
Title of the study (Brief title)	Randomized phase II study of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1.
Region	Japan

Condition
Condition	squamous cell carcinoma of the lung
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of nab-PTX plus CBDCA followed by maintenance nab-PTX or TS-1 plus CBDCA followed by maintenance TS-1 as first-line treatment in patients with stage IIIB/IV squamous cell carcinoma of the lung.
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(PFS)
Key secondary outcomes	quality of life(QOL) response rate(RR) disease control rate(DCR) overall survival(OS) maintenance therapy shift rate PFS from the start of maintenance therapy adverse events(AEs)

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	nab-PTX plus CBDCA followed by maintenance nab-PTX.
Interventions/Control_2	TS-1 plus CBDCA followed by maintenance TS-1.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytologically confirmed squamous cell lung cancer. 2.Stage IIIB/IV without indication for radical thoracic irradiation or postoperative recurrence. 3.No prior chemotherapy or postoperative recurrent disease without adjuvant chemotherapy or with at least six months interval from the last dosage of adjuvant chemotherapy. 4.Age > or = 20 years 5.Eastern Cooperative Oncology Group performance status of 0-1 6.Tumor has the Measurable lesion. 7.Adequate organ function, Adequate organ function within 2 weeks 7-1:Leukocyte count > or = 3,000/mm3 7-2:Neutrophil count > or = 1,500/mm3 7-3:Hemoglobin > or = 9.0 g/dl 7-4:Platelet count > or = 100,000/mm3 7-5:Aspartate aminotransferase and alanine aminotransferase levels < or = 100 IU/L 7-6:Total bilirubin < or = 1.5 mg/dl 7-7:Serum creatinine < or = 1.2 mg/dl 7-8:Creatinine clearance; > or = 60mL/min 7-9:Acceptable cardiac function 7-10:Peripheral neuropathy < or = grade 1 8.Estimating Survival more than 3 months. 9.Capable of oral intake 10.Written informed consent from the patients.
Key exclusion criteria	1.History of hypersensitivity to drugs or albumin. 2.Severe infection 3.Significant comorbid disease (paresis of intestine, ileus, GI bleeding, uncontrolled angina pectoris, cardiac disease, etc) 4.Massive pleural and cardiac effusion and ascites required for tube drainage. 5.Cases of administration in the flucytosine. 6.Patients with superior vena cava syndrome. 7.Active synchronous malignant neoplasm. 8.Interstitial pneumonia or pulmonary fibrosis detectable on Chest X ray. 9.Brain metastases patients in need of treatment, such as an anti-seizure medication and steroids or have symptoms. 10.Cases of post-radiation to the primary tumor. 11.Cases of palliative bone or brain irradiation within two weeks of proposed entry to this study. 12.Uncontrolled psychiatric disease. 13.Pregnancy, breast feeding and suspected pregnancy. 14.Other conditions not suitable for this study.
Target sample size	58

Research contact person
Name of lead principal investigator	Seisuke Nagase
Organization	Internationanl University of Health and Welfare
Division name	Respiratory Disease center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Email	snagase@iuhw.ac.jp

Public contact
Name of contact person	Seisuke Nagase
Organization	Internationanl University of Health and Welfare
Division name	Respiratory Disease center
Address	1-4-3 Mita, Minato-ku, Tokyo, Japan
TEL	03-3451-8121
Homepage URL
Email	snagase@iuhw.ac.jp

Sponsor
Institute	Internationanl University of Health and Welfare, Respiratory Disease center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	慶応義塾大学病院　呼吸器内科　(東京都） 国立国際医療研究センター　呼吸器内科　(東京都） 災害医療センター　呼吸器内科　(東京都） 聖路加国際病院　呼吸器内科　(東京都） 帝京大学医学部附属病院　呼吸器・アレルギー内科　(東京都） 東京女子医科大学病院　呼吸器内科　(東京都） 東京医科大学病院　呼吸器・甲状腺外科　(東京都）

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 08 Month 18 Day
Anticipated trial start date	2014 Year 01 Month 06 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 01 Month 20 Day
Last modified on	2018 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015079