UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Title of the study (Brief title)	Phase II study of Carboplatin and alternate-day administrations of TS-1 in patients with advanced squamous cell lung cancer.
Region	Japan

Condition
Condition	Squamous cell carcinoma of the lung
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and feasibilty for Carboplatin and alternate-day administrations of TS-1 in patients with squamous cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate (CR+PR+SD)
Key secondary outcomes	1.Overall survival 2.Progression-free survival from induction chemotherapy 3.Progression-free survival from maintenance chemotherapy 4.Percrntages of patients who received maintenance chemotherapy 5.Response rate 6.Toxicities

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 chemotherapy with Carboplatin and alternate-day administrations of TS-1 for all registered patients. Maintenance chemotherapy with alternate-day administrations of TS-1 for non-PD patients.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Histologically or cytologically confirmed squamous cell carcinoma of the lung 2.Stage IIIB/IV 3.Age >=20 4.PS(Eastern Cooperative Oncology Group:ECOG):0-2 5.Measurable lesion 6.Capable of oral intake 7.Adequate organ functions neutrophils >=1,500/mm3 platelets >=100,000/mm3 hemoglobin >=9.0g/dL total bilirubin <=2.0mg/dL AST(GOT)/ALT(GPT) <=100IU/L PaO2 >= 60torr or SpO2 >=90% creatinine clearance >=30mL/min 8.Estimated life expectancy of at least 3 months 9.With written informed consent
Key exclusion criteria	1.Contraindication of TS-1, CBDCA 2)Patients received adjuvant chemotherapy 3.Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy 4.Active infection 5.HBs antigen positive 6.Severe complications, such as ileus, heart failure and renal failure 7.Continuous diarrhea 8.Massive pleural effusion and ascites 9.Active concomitant malignancy 10.Patients under treatment with flucytosine, phenytoin or warfarin potassium 11.Patients under treatment with steroids 12.Inadequate physical condition, as diagnosed by primary physician
Target sample size	35

Research contact person
Name of lead principal investigator	Young Hak Kim
Organization	Kyoto University Hospital
Division name	Respiratory Medicine
Address	54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
TEL	075-751-3830
Email	ekim@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroki Nagai
Organization	Kyoto University Hospital
Division name	Respiratory Medicine
Address	54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
TEL	075-751-3830
Homepage URL
Email	hwithe@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	京都大学附属病院（京都府）

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 11 Month 01 Day
Anticipated trial start date	2012 Year 12 Month 01 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	2012 Year 11 Month 10 Day
Last modified on	2017 Year 11 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010930