UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of S-1 for non-small lung cancer after failure of two or three prior chemotherapy regimens
Title of the study (Brief title)	Phase II study of 3rd-line S-1 for NSCLC
Region	Japan

Condition
Condition	Non Small Cell Lung Cancer (NSCLC)
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this phase II trial is to evaluate the safety and efficacy of single S-1 administration as a third-line chemotherapy for non-small cell carcinoma.
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 by CT scan and physical exam at the end of every even course or every 4 weeks until progressive disease (PD) or initiation of new anticancer therapy
Key secondary outcomes	Overall survival every 2 months after PD for up to 12 months following the end of patient accrual Duration of response by CT scan and physical exam at the end of every even course or every 4 weeks until PD or initiation of new anticancer therapy Progression-free survival by CT scan and physical exam every 4 weeks Safety by laboratory evaluations and assessment of adverse events on days 1, 8, and 15 of every course, EOS, periodically, and 30 days after treatment

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	Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 4 weeks until progressive disease and then every 2 months thereafter.
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 and/or cytologically proven non-small cell carcinoma. 2.Prior chemotherapy with more than two regimens, necessarily including at least one platinum-based (CDDP or CBDCA) combination. Use of molecular-targeting drugs and adjuvant therapy are countable to the prior regimens. Prior concurrent therapies including endocrine therapy, surgery, and radiotherapy are acceptable for the inclusion. 3.The presence of measurable disease. 4.An ECOG performance status ranging from 0 to 2. 5.Aged greater than 20 year-old. 6.Major organs are in normal conditions. White blood cell count => 3000/mm3 Absolute granulocyte count => 1500/mm3 Hemoglobin => 9.0g/dL Platelet count => 100,000/mm3 Serum bilirubin <= 1.8 mg/dL or 1.5 times upper limit of normal AST, ALT <= 2 times upper limit of normal Serum creatinine <= 1.5 mg/dL Oxyhemoglobin satulation (SpO2) => 90% 7.Life expectancy should exceed at least 3 months. 8.All participants have given written informed consent.
Key exclusion criteria	1. Previous histories of drug allergy, which may increase the risk of this study. 2. Serious concomitant infection or high-grade fever exceeding 38 deg C or more. 3. Usages of oral steroids or immunosuppressive drugs. 4. Serious complications including severe cardiovascular disease, cerebrovascular disease, severe hypertension, active peptic ulcer, uncontrolled diabetes. 5. Interstitial pneumonia or pulmonary fibrosis on chest X-ray or CT scans. 6. Any prior treatments with S-1 or UFT. 7. Any coelomic fluids (pleural, pericardial, or ascites), which require emergent treatment. 8. Symptomatic brain metastases. 9. Other active multiple cancers. 10. Severe heart diseases. 11. Psychiatric conditions, which may increase the risks associated with the study participation. 12. Pregnant or nursing women. 13. Other conditions, on which the judgment of the investigator would make the patient inappropriate for entry.
Target sample size	40

Research contact person
Name of lead principal investigator	Yutaka Nishigaki
Organization	National Hospital Organization Asahikawa Medical Center
Division name	Department of Clinical Research
Address	7-4048, Hanasaki-cho, Asahikawa 070-8644, Japan
TEL	0166.51.3161
Email	yutakan@asahikawa.hosp.go.jp

Public contact
Name of contact person	Yutaka Nishigaki
Organization	National Hospital Organization Asahikawa Medical Center
Division name	Department of Clinical Research
Address	7-4048, Hanasaki-cho, Asahikawa 070-8644, Japan
TEL	0166.51.3161
Homepage URL
Email	yutakan@asahikawa.hosp.go.jp

Sponsor
Institute	National Hospital Organization Asahikawa Medical Cencer
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	国立病院機構旭川医療センター

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 04 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 07 Month 27 Day
Anticipated trial start date	2010 Year 08 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	2010 Year 08 Month 03 Day
Last modified on	2016 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004750