UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Title of the study (Brief title)	Phase II Study of Alternate-day Administration of S-1 plus Carboplatin in Elderly Patients with Previously Treated Non-small Cell Lung Cancer
Region	Japan

Condition
Condition	Non-small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of alternate-day administration of S-1 plus carboplatin in elderly patients with previously treated non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression-free survival
Key secondary outcomes	Response rate, safety and adverse event, 1-year survival rate, overall survival

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 alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) plus carboplatin at the dose of area under the curve 5 (Day 1) every 3 weeks, up to 4 cycles. Continuation maintenance chemotherapy with alternate-day administration of S-1 (80mg/m2/day on Mon, Wed, Fri, and Sun) until PD is observed.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age of 75 years or older 2) Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) 3) Incurable NSCLC with stage IIIB or stage IV 4) Patients with NSCLC previously treated with platinum-based chemotherapy within two regimens, or three regimens including EGFR-TKI (Gefitinib or Erlotinib). In both cases, platinum-based chemotherapy must have been delivered before single agent cytotoxic chemotherapy. In patients who have undergone thoracic surgery and platinum-based adjuvant chemotherapy, platinum-based adjuvant chemotherapy could be considered as first line chemotherapy when the recurrence is observed within 12 months after surgery. Patients who have undergone chemoradiotherapy have to be excluded. Patients who have received two regimens of platinum-based chemotherapy have to be excluded. 5) Performance Status (Eastern Cooperative Oncology Group: ECOG) 0-2 6) Both measurable and non-measurable lesions are acceptable as far as objective lesions are detectable by means of X-ray, CT, MRI, and RI within 28days before the entry. 7) Capable of oral intake 8) Adequate organ functions within 14 days before the entry i) White blood cell count 3500/mm3 or over ii) Neutrophil count 1500/mm3 or over iii) Platelet count 100,000/m3 or over iv) Hemoglobin 9.0g/dL or over v) Total bilirubin 2.0mg/dL or under vi) AST/ALT 100IU/L or under vii) PaO2 60Torr or over, or SpO2 90% or over viii) Creatinine clearance 50mL/min or over 9) Estimated life expectancy of at least 12 weeks 10) With written informed consent
Key exclusion criteria	1) Past history of severe drug hypersensitivity 2) Severe bone marrow suppression, renal dysfunction, or liver dysfunction 3) Treatment history of S-1, except for the cases in which S-1 had been administered as adjuvant chemotherapy and recurrence was observed more than 1 year after thoracic surgery 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer 5) Severe complication such as ileus, interstitial pneumonia, uncontrolled diabetes, heart failure, renal dysfunction, liver dysfunction, active digestive ulcer, and acute myocardial infarction or angina pectoris within six months 6) Diarrhea graded 2 or more 7) Active infectious disease in need of systemic administration of antibiotics 8) Uncontrolled pleural effusion, ascites, and pericardial effusion which needs drainage 9) Uncontrolled symptomatic brain metastasis 10) Systemic administration of steroid 11) Patients with psychiatric disease or symptoms, who seem to have difficulty in participating in the study 12) Any patients judged by the investigator to be unfit to participate in the study
Target sample size	32

Research contact person
Name of lead principal investigator	TAKEDA Takayuki
Organization	Uji-Tokushukai Medical Center
Division name	Department of Respiratory Medicine
Address	86, Kasugamori, Ogura-cho, Uji-city, Kyoto
TEL	0774-20-1111
Email	dyckw344@yahoo.co.jp

Public contact
Name of contact person	TAKEDA Takayuki
Organization	Uji-Tokushukai Medical Center
Division name	Department of Respiratory Medicine
Address	86, Kasugamori, Ogura-cho, Uji-city, Kyoto
TEL	0774-20-1111
Homepage URL
Email	dyckw344@yahoo.co.jp

Sponsor
Institute	Tokushukai Group Oncology Project
Institute
Department

Funding Source
Organization	Uji-Tokushukai Medical Center
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	宇治徳洲会病院、札幌東徳洲会病院、千葉徳洲会病院、湘南鎌倉総合病院、湘南藤沢徳洲会病院、八尾徳洲会病院、大隅鹿屋病院

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 10 Day
Anticipated trial start date	2013 Year 07 Month 08 Day
Last follow-up date	2016 Year 07 Month 08 Day
Date of closure to data entry	2016 Year 07 Month 08 Day
Date trial data considered complete	2016 Year 07 Month 08 Day
Date analysis concluded	2016 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 18 Day
Last modified on	2018 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012863