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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000001743
Receipt No. R000002102
Scientific Title Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Date of disclosure of the study information 2009/03/02
Last modified on 2011/11/13

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Basic information
Public title Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Acronym Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC
Scientific Title Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer
Scientific Title:Acronym Phase II study of high-dose thoracic and cisplatin and vinorelbine for stage III NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of high-dose thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy for inoperable stage III non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 2-year survival rate
Key secondary outcomes Response rate, overall survival, incidence of toxicity

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 Cisplatin 80mg/m2 on day 1 + vinorelbine 20mg/m2 on days 1 and 8, repeated every 4 weeks for 4 cycles,
Thoracic radiotherapy 72 Gy/36 fractions
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1. a histological or cytological diagnosis of NSCLC; 2. inoperable clinical stage III; 3. no prior treatment; 4. measurable disease; 5. the percent volume of the normal lung receiving 20 Gy or more (V20) equal to or less than 30%; 6. age between 20 and 74 years; 7. Performance Status of 0 - 1; 8. adequate organ function; and 9. written informed consent.
Key exclusion criteria 1. malignant pleural or pericardial effusion; 2. contralateral hilar lymph node metastasis, intralobular metastasis or lymphangitis carcinomatosa; 3. serious concomitant medical illness; 4. synchronous active malignancies; 5. history of chemotherapy or thoracic radiotherapy; 6. pregnancy or breast feeding.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohide Tamura
Organization National Cancer Center Hospital
Division name Division of Internal Medicine and Thoracic Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ikuo Sekine
Organization National Cancer Center Hospital
Division name Division of Internal Medicine and Thoracic Oncology
Zip code
Address Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email isekine@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Hyogo Cancer Center
KKR Sapporo Medical Center
National Hospital Organization Hokkaido Cancer Center
Tochigi Cancer Center
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 03 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Suspended
Date of protocol fixation
2009 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2014 Year 02 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 03 Month 01 Day
Last modified on
2011 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002102

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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