UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized phase II trial of daily administrations versus alternate-day administrations of S-1 in patients with advanced non-small cell lung cancer
Title of the study (Brief title)	NJLCG1102
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of daily administrations versus alternate-day administrations of S-1 in patients with non-small cell lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Safety (Incidence of grade3 or higher Adverse Events)
Key secondary outcomes	Response Rate Progression-free Survival Overall Survival Completion rate of 1st course

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	Daily administrations: S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 28, which is followed by 14 days rest.
Interventions/Control_2	Alternate-day administrations: S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA on Mondays, Wednesdays, Fridays and Sundays
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 NSCLC 2)Unresectable or reccurent NSCLC 3)With or without measurable lesions 4)With at least 1 prior chemotherapy 5)Age of 20 years or older 6)ECOG performance status 2 or less 7)With adequate major organ functions within 14 days before randomization, as defined below: *White blood cell count >= 3,000/mm3 *Neutrophil count >= 1,500/mm3 *Platelet count >= 100,000/mm3 *Hemoglobin >= 9.0 g/dL *AST <= 2.5 x ULN *ALT <= 2.5 x ULN *Total bilirubin <= 1.5 mg/dL *PaO2 >= 60 Torr or SpO2 >= 94% *Estimated CCr >= 50 mL/min. 8)Sufficient oral intake 9)Written informed consent
Key exclusion criteria	1)With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 2)Contraindication with S-1 3)With double cancer, multiple cancer 4)With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 5)With concurrent disease 6)With symptomatic brain metastasis 7)With severe diarrhea 8)Previous treatment with fluoropyrimidines such as S-1, UFT, 5-FU 9) Current use of flucytosine 10)Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 11)Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	60

Research contact person
Name of lead principal investigator	Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	Dept. of Respiratory Medicine
Address	47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan
TEL	81-22-384-3151
Email	maemondo-ma693@miyagi-pho.jp

Public contact
Name of contact person	Makoto Maemondo
Organization	Miyagi Cancer Center
Division name	Dept. of Respiratory Medicine
Address	47-1 Nodayama, Medesima-shiote, Natori, Miyagi, 981-1293, Japan
TEL	81-22-384-3151
Homepage URL
Email	maemondo-ma693@miyagi-pho.jp

Sponsor
Institute	North Japan Lung Cancer Study Group
Institute
Department

Funding Source
Organization	North Japan Lung Cancer Study Group
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	YES
Study ID_1	NJLCG1102
Org. issuing International ID_1	North Japan Lung Cancer Study Group
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 28 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 12 Month 24 Day
Anticipated trial start date	2012 Year 01 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	2011 Year 12 Month 28 Day
Last modified on	2016 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008215