UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002381 |
|---|---|
| Receipt number | 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 10:19:01 |
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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
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
t-kawaguchi@kch.hosp.go.jp
Sponsor or person
Institute
National Hospital Study Group for Lung Cancer
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002920
