UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000060
Receipt number 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 13:56:07

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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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.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