UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II Trial of Carboplatin plus S-1 for Previously Untreated Elderly Patients with Advanced Non-small-cell lung cancer with Wild Type Epidermal Growth Factor Receptor (OLCSG1202)
Title of the study (Brief title)	Phase II Trial of CBDCA + S-1 for 1st line Elderly NSCLC with Wild Type EGFR (OLCSG1202)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The present study was planned with the objective of investigating the combination of carboplatin and S-1 in the treatment of previously untreated elderly patients with advanced non-small-cell lung cancer. This study is designed as a phase II study of assessment of the efficacy and tolerability.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate
Key secondary outcomes	Progression Free Survival, Overall Survival, Quality of Life, Adverse Event, Effects of complication, Compliance with 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	Four cycles of Carboplatin(AUC 5, Day 1)+ S-1 (80mg/m2/day, 2week on/2week off) followed by maintenance S-1 monotherapy in 4-week cycles until progression disease
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed non-small-cell lung cancer with Chemo-naive patients 2) Patients who have measurable lesion or evaluable lesion by RECIST 3) Patients with Chemo-naive patients Stage three/four without any indications for radiotherapy 4) Patients aged over 70 years old 5) ECOG PS 0-2 6) Patients who have measurable lesion or evaluable lesion by RECIST 7) Adequate bone mallow function, evaluated within 14 days before enrollment (registration day is day1, and on the same day two weeks ago, is impossible) as WBC >= 3,000/mm3 Neu >= 1,500/mm3 Plt >= 150,000/mm3 Hb >= 9 g/dL 8) Adequate liver function T.Bil <= 1.5 mg/dL AST/ALT <= 2.5 * upper limit of normal 9) Adequate renal function Serum Cr <= upper limit of normal. 10) Adequate pulmonary function PaO2 >= 60 Torr or SpO2 >= 90 % (both at rest and room air) 11) Patients who underwent palliative radiation therapy within one week were excluded 12) Patients who are able to take orally 13) Written informed consent from the patients
Key exclusion criteria	1) Patients with brain metastases with the clinical symptoms 2) Patients with disease-free interval is less than five years without treatment and even in patients with cancer or metachronous duplication of activity 3) Patients who underwent radiation therapy within one weeks (a palliative radiation therapy to the lesion, e.g. bone metastasis, was excepted from this exclusion) 4) Patients with a history of severe drug allergy 5) Pregnancy, breast feeding or wish of future bearing 6) Patients with severe complication Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray History of severe heart disease (uncontrollable arrhythmia, uncontrollable angina pectoris, congestive heart failure, etc. within 3 months) Uncontrollable diabetes mellitus Patients with severe infection Patients has pleural effusion, pericardial effusion and ascites to be treated 7) Patients who need to be treated by radiotherapy in an urgent 8) concomitant therapy with other pyrimidine fluoride antineoplastic agents 9) concomitant therapy with warfarin 10) concomitant therapy with dabigatran etexilate 11) Principal investigator cases that are deemed inappropriate
Target sample size	32

Research contact person
Name of lead principal investigator	Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7227
Email	kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person	Katsuyuki Hotta
Organization	Okayama University Hospital
Division name	Department of Respiratory Medicine
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7227
Homepage URL
Email	khotta@md.okayama-u.ac.jp

Sponsor
Institute	Okayama Lung Cancer Study Group
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)	None

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

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 07 Month 26 Day
Anticipated trial start date	2012 Year 11 Month 16 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	Published
URL releasing results	http://www.lungcancerjournal.info/article/S0169-5002(17)30471-3/abstract
Results	Carboplatin plus S-1 had favorable efficacy and tolerable toxicity for the elderly with NSCLC. This study met the predesigned primary endpoint, and the regimen seems to be a potent treatment option. Low TP expression in tumors might serve as a predictive maker of a better DCR. We need to conduct further studies to evaluate whether this combination is superior to the standard first-line treatment for the elderly.
Other related information

Management information
Registered date	2012 Year 11 Month 16 Day
Last modified on	2017 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010976