UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Title of the study (Brief title)	A Phase II Clinical Trial of CBDCA and TS-1 concurrent chemotherapy followed by TS-1 Maintenance Therapy for Advanced and Recurrent Squamous Cell Lung Cancer: SMILE Trial
Region	Japan

Condition
Condition	Non-small cell lung cancer (squamous cell carcinoma)
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of carboplatin and S-1 followed by S-1 maintenance therapy for advanced or recurrent non-small cell lung cancer (squamous cell carcinoma)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	1-year survival rate
Key secondary outcomes	Progression free survival(PFS) Overall survival (OS) Objective response rate (ORR) 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	Induction chemothrapy Carboplatin: AUC=5, day 1 TS-1: 80mg/m2, day 1-14 q4w, 4 cycles Maintenance chemotherapy TS-1 maintenance: 80mg/m2, day 1-14 q4w, Until PD
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) Histological or cytological confirmed squamous cell lung carcinoma. 2) Patients with unresectable stageIIIb- IV or postoperative recurrence. 3) Over 20 yeas old, under 75 years old. 4) ECOG PS 0-1. 5) Patients have the prospective for surviving more than 3 months. 6) Patients who are able to take oral medication. 7) Adequate main organ and bone marrow function filled below criteria within 14 days before registration. 1. Leukocyte counts >= 4,000/mm3 <=12,000 /mm3 2. Neutrophil counts>=1,500 /mm3 3. Platelets >= 100,000 /mm3 4. Hemoglobin >=9.0 g/dL 5. Total bilirubin <= 1.5 mg/dL 6. AST and ALT <= 100 IU/L 7. PaO2 >= 60 Torr or SpO2 >= 90% 8. Serum creatinin clearance >= 60 ml/min (Cockcroft-Gault) 8) Patients providing written informed consent.
Key exclusion criteria	1) Any previous first line treatment with radiotherapy (including chemo radiotherapy) 2) Administration contraindication to Carboplatin and S-1. 3) Severe complications, such as cardiac failure, renal failure, hepatic failure, hemorrhagic gastric or duodenal ulcer, ileus, and uncontrollable or insulin-treated diabetic. 4) Severe drug allergies or history of drug hypersensitivity 5) Symptomatic or apparent interstitial pneumonia/lung fibrosis on CT scan or X-ray image findings (Included positive suspicion or history of them). 6) Severe watery diarrhea 7) With active infection. Fever higher than 38 degrees celsius. 8) HBsAg positive patients 9) The brain metastases which require emergent treatment. 10) Patients with ascites, pleural or pericardial effusion requiring drainage. 11) Patients undergoing UFT or TS-1 adjuvant therapy. The case postoperative recurrence within 6 months after adjuvant therapy. 12) Active concomitant malignancy with disease-free duration to be within 3 years. 13) Required to continue Flucytosine (5- FC), phenytoin and warfarinpotassium. 14) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 15) The case that is judged to be inadequacy for this study
Target sample size	30

Research contact person
Name of lead principal investigator	Tetsu Shinkai, M.D., Ph.D
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of thoracic oncology and medicine
Address	160 Kou Minami-umemoto, Matsuyama, Ehime 791-0280, Japan
TEL	089-999-1111
Email	tshinkai@shikoku-cc.go.jp

Public contact
Name of contact person	Naoyuki Nogami, M.D., Ph.D
Organization	National Hospital Organization Shikoku Cancer Center
Division name	Department of thoracic oncology and medicine
Address	160 Kou Minami-umemoto, Matsuyama, Ehime 791-0280, Japan
TEL	089-999-1111
Homepage URL
Email	nnogami@shikoku-cc.go.jp

Sponsor
Institute	National Hospital Organization Shikoku Cancer Center
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	国立病院機構　四国がんセンター（愛媛県松山市） 松山赤十字病院（愛媛県松山市） 市立宇和島病院（愛媛県宇和島市）

Other administrative information
Date of disclosure of the study information	2012 Year 02 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 11 Month 25 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2016 Year 10 Month 01 Day
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	2012 Year 02 Month 07 Day
Last modified on	2019 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008463