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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000027
Receipt No. R000000060
Scientific Title Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)
Date of disclosure of the study information 2005/07/22
Last modified on 2014/02/21

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Basic information
Public title Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)
Acronym Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)
Scientific Title Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)
Scientific Title:Acronym Docetaxel(D) versus docetaxel plus gemcitabine(DG) for second-line treatment of non-small cell lung cancer (NSCLC) : Results of a JCOG randomized trial (JCOG0104)
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 combination regimen of Docetaxel and Gemcitabine provides better overall survival than Docetaxel alone in patients with previously treated NSCLC
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 Adverse events
Progression-free survival

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 NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Docetaxel alone
Interventions/Control_2 Docetaxel and Gemcitabine
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 and/or cytologically proven NSCLC
2) Advanced Stage (IV or IIIB)
3) One prior platinum-based chemotherapy
4) Excluded either docetaxel or gemcitabine
5) Age: 20 to 75
6) PS (ECOG scale): 0, 1
7) Adequate organ function
8) WBC>=4,000 /mm3, ANC>=2,000 /mm3, Hb>=9.5 g/dL, PLT>=100,000 /mm3
9) AST/ALT <=2.5 x Normal Upper Limit, T-Bil <= 1.5 mg/dL
10) Creatinine <= 1.2 mg/dL
11) PaO2 >=70 mmHg (Room air)
12) Written informed consent
Key exclusion criteria 1) Symptomatic brain metastasis
2) Double cancer
3) Superior vena cava syndrom
4) Massive pleural effusion or ascitis
5) Spiral compression
6) Severe hypertension
7) Diabetis melitus treated with insulin
8) Concommitant infectious disease excluded hepatic fever
9) Interstitial lung disease
10) Hypersinsitivity to Polysorbate 80
11) Need to treatment with steroid, ketoconazole, nifedipine or erithromycin
12) Psycologic illness
13) Women during pregbnancy or lacteted
Target sample size 284

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichi Negoro, MD
Organization Osaka City General Hospital
Division name Department of Plumonay Medicine
Zip code
Address 2-13-22Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Takeda, MD
Organization JCOG0104 Coordinating Office
Division name Department of Plumonay Medicine, Osaka City General Hospital
Zip code
Address 2-13-22Miyakojimahondori, Miyakojima-ku, Osaka, 534-0021 JAPAN
TEL
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構北海道がんセンター(北海道)
旭川医科大学(北海道)
茨城県立中央病院・茨城県立地域がんセンター(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)
埼玉県立がんセンター(埼玉県)
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)
都立駒込病院(東京都)
国立国際医療センター(東京都)
癌研究会附属病院(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)
愛知県がんセンター(愛知県)
国立病院機構名古屋医療センター(愛知県)
県立愛知病院(愛知県)
大阪市立大学医学部(大阪府)
近畿大学医学部(大阪府)
大阪府立成人病センター(大阪府)
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)
国立病院機構刀根山病院(大阪府)
大阪府立病院(大阪府)
大阪市立総合医療センター(大阪府)
神戸市立中央市民病院(兵庫県)
兵庫医科大学(兵庫県)
兵庫県立成人病センター(兵庫県)
国立病院機構四国がんセンター(愛媛県)
九州大学病院(福岡県)
長崎大学医学部・歯学部附属病院(長崎県)
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 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/19164456
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 Terminated
Date of protocol fixation
2001 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2002 Year 01 Month 01 Day
Last follow-up date
2004 Year 06 Month 01 Day
Date of closure to data entry
2005 Year 01 Month 01 Day
Date trial data considered complete
2005 Year 01 Month 01 Day
Date analysis concluded
2005 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 22 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=R000000060

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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