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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000060
Receipt No. R000000105
Scientific Title Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
Date of disclosure of the study information 2005/08/15
Last modified on 2014/02/21

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Basic information
Public title Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
Acronym Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
Scientific Title Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
Scientific Title:Acronym Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients with Locally Advanced Non-small Cell Lung Cancer(JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)
Region
Japan

Condition
Condition Non-small cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether radiotherapy with carboplatin would result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NCSLC
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes Response rate, Adverse events, Progression-free survival, Pattern of progression/relapse

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Radiotherapy alone
Interventions/Control_2 CBDCA and Radiotherapy
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
71 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Histologically and/or cytologically proven NSCLC,
(2) Unresectable disease,
(3) Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions,
(4) a required radiation field of less than one half of one lung, (5) measurable disease,
(6) no previous chemotherapy or radiotherapy,
(7) age>=71,
(8) inappropriate to recieve cisplatin-based combination chemotherapy,
(9) ECOG PS of 0-2,
(10) adequate bone marrow, lung, hepatic, renal function,
(11) written informed consent.
Key exclusion criteria (1) active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, severe other comorbity,
(2) synchronous cancer or metachronous (within 5 years) malignancy,
(3) interstitial pneumonia or active lung fibrosis on chest X-ray,
(4) severe chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma,
(5) pleural or pericardial effusion,
(6) a history of severe hypersensitivity, (7) mental disorder,
(8) judging of inappropriate condition for this study by physician.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Atagi, MD
Organization Kinki-Chuo Chest Medical Center
Division name Department of Internal Medicine
Zip code
Address 1180 Nagasone, Sakai, Osaka, 591-8555, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Atagi, MD
Organization JCOG0301 Coordinating Office
Division name Department of Internal Medicine, Kinki-Chuo Chest Medical Center
Zip code
Address 1180 Nagasone, Sakai, Osaka, 591-8555, Japan
TEL 072-252-3021
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00132665
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構道北病院(北海道)
東北大学病院(宮城県)
茨城県立中央病院・茨城県地域がんセンター(茨城県)
栃木県立がんセンター(栃木県)
国立病院機構西群馬病院(群馬県)
群馬県立がんセンター(群馬県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
国立国際医療センター戸山病院(東京都)
虎の門病院(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立市民病院(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
岐阜市民病院(岐阜県)
静岡県立静岡がんセンター(静岡県)
愛知県がんセンター中央病院(愛知県)
愛知県がんセンター愛知病院(愛知県)
大阪市立大学医学部附属病院(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立呼吸器・アレルギー医療センター(大阪府)
国立病院機構近畿中央胸部疾患センター(大阪府)
大阪府立病院機構大阪府立急性期・総合医療センター(大阪府)
大阪市立総合医療センター(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
兵庫医科大学(兵庫県)
兵庫県立がんセンター(兵庫県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
熊本地域医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22622008
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
2003 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2003 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 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
2005 Year 08 Month 15 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000105

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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