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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000079
Receipt No. R000000116
Scientific Title 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)
Date of disclosure of the study information 2005/09/12
Last modified on 2016/09/15

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Basic information
Public title 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)
Acronym Cisplatin and S-1 with radiotherapy for locally advanced non-small-cell lung cancer
Scientific Title 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)
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsune Tanimoto
Organization Okayama University Hospital
Division name Hematology, Oncology, Respiratory Medicine
Zip code
Address 2-5-1 Shikata-cho, Okayama 700-8558
TEL 086-235-7227
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nagio Takigawa
Organization Okayama Lung Cancer Study Group Coordinating Office
Division name Department of Respiratory Medicine, Okayama University Hospital
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S0169500214004
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2005 Year 08 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000000116

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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