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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002381
Receipt No. R000002920
Scientific Title Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer
Date of disclosure of the study information 2009/08/26
Last modified on 2014/02/25

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Basic information
Public title Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer
Acronym NHO0501
Scientific Title Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer
Scientific Title:Acronym NHO0501
Region
Japan

Condition
Condition inoperable locally advanced stage IIIA/IIIB 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 thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes tumor response
Key secondary outcomes safety, 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 thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1.Histologically or cytologically confirmed non-small cell lung cancer
Stage IIIA T1N2M0, T2N2M0, T3N2M0
Stage IIIB AnyTN3M0, T4AnyNM0
(Except for pulmonary atelectasis of a ipsilateral lung in T3,and malignant pleural effusion in T4)
(Acceptable for contralateral mediastinal lymph node metastasis in N3. Except for contralateral hilar lymph node metastasis and contralateral and ipsilateral supraclavicular lymph node metastasis in N3)
2.No prior chemotherapy
3..measurable disease (2cm on chest CT)
Eastern Cooperative Oncology Group performance status of 0 to 1
4.Age between 20 and 74 years
5.Adequate hematologic, hepatic, renal, and cardiac function
WBC 4,000/microL
Absolute neutrophil count 2,000/microL
Platelet count 100,000/microL
Hemoglobin 9.5 g/dL
AST and ALT 2 times upper limit of normal
Total bilirubin 1.5mg/dL
Creatinine upper limit of normal
Creatinine clearance 60mL/min
PaO2 70 torr
6.Life expectancy more than 3 months
7.Written informed consent
Key exclusion criteria 1.Infections
2.Apparent interstitial pneumonitis or fibrosis on chest CT
3.Irradiation field larger than half of a ipsilateral lung
4.Ileus
5.Neuropathy (motor, sensory)
6.Severe complications(liver cirrhosis, diabetes mellitus, Clinically significant heart disease, etc.)
7.Myocardial infarction within the last 6 months
8.Another active cancer
9.Pregnancy, intent to become pregnant, or breast-feeding
10.Other non eligible cases judged by investigators
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhisa Tamura
Organization National Hospital Study Group for Lung Cancer
Division name clinical trial
Zip code
Address 1180 Nagasone-cho, Sakai, Osaka, Japan
TEL 072-252-3021
Email tamura-in@tokyo-hosp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoya Kawaguchi
Organization NHO Kink-chuo Chest Medical Center
Division name Internal medicine
Zip code
Address 1180 nagasone-cho, kita-ku, sakai, osaka
TEL 072-252-3021
Homepage URL
Email t-kawaguchi@kch.hosp.go.jp

Sponsor
Institute National Hospital Study Group for Lung Cancer
Institute
Department

Funding Source
Organization National Hospital Study Group for Lung Cancer
Organization
Division
Category of Funding Organization
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
2009 Year 08 Month 26 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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 12 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 25 Day
Last modified on
2014 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002920

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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