UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of cisplatin and S-1 with concurrent thoracic radiation therapy for inoperable locally advanced non-small-cell lung cancer (OLCSG 0501)
Title of the study (Brief title)	Cisplatin and S-1 with radiotherapy for locally advanced non-small-cell lung cancer
Region	Japan

Condition
Condition	inoperable locally advanced non-small-cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of phase I portion is to determine the maximum-tolerated doses and the recommended dose of cisplatin and S-1 for the phase II study when combined with concurrent thoracic radiotherapy. The objective of phase II portion is to evaluate objective response rate and safety at the recommended dose level.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I: maximum-tolerated doses and the recommended dose for phase II Phase II: Response rate
Key secondary outcomes	Adverse events, overall survival, progression-free survival, pattern of progression/relapse, treatment compliance

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	cisplatin and S-1 with concurrent thoracic radiation therapy
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Histologically and/or cytologically proven NSCLC No prior surgery, chemotherapy, or radiotherapy Age ≤ 75 Unresectable stage IIIA or IIIB ECOG performance status 0 or 1 Measurable disease Ample bone marrow, lung, hepatic, and renal function Signed informed consent
Key exclusion criteria	Involvement of contralateral hilar node, dissemination to pleura/pericardium, or malignant pleural/pericardial effusion Active concomitant malignancy History of chemotherapy or thoracic radiotherapy for previous malignancy Interstitial pneumonia Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Judging of inappropriate condition for this study by physician
Target sample size	60

Research contact person
Name of lead principal investigator	Mitsune Tanimoto
Organization	Okayama University Hospital
Division name	Hematology, Oncology, Respiratory Medicine
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Email

Public contact
Name of contact person	Nagio Takigawa
Organization	Okayama Lung Cancer Study Group Coordinating Office
Division name	Department of Respiratory Medicine, Okayama University Hospital
Address	2-5-1 Shikata-cho, Okayama 700-8558
TEL	086-235-7227
Homepage URL
Email

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)

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	2005 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 08 Month 05 Day
Anticipated trial start date	2005 Year 09 Month 01 Day
Last follow-up date	2011 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2012 Year 01 Month 01 Day
Date analysis concluded	2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S0169500214004
Results
Other related information

Management information
Registered date	2005 Year 08 Month 25 Day
Last modified on	2016 Year 09 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000116