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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000146
Receipt No. R000000211
Scientific Title Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Date of disclosure of the study information 2005/09/09
Last modified on 2014/12/04

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Basic information
Public title Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Acronym Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)
Scientific Title Randomiazed controlled trial comparing docetaxel-cisplatin combination with docetaxel alone in elderly patients with advanced non-small-cell lung cancer(JCOG0207)
Scientific Title:Acronym Cisplatin-containing combination vs single-agent chemotherapy in elderly patients with adavanced non-small-cell lung cancer (JCOG0207 Elderly NSCLC/D vs DP)
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 the efficacy of docetaxel-cisplatin combination in comparison to docetaxel alone for elderly patients with advanced non-small-cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes Toxicity, Progression-free survival, Response rate, Symptom score

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 administered by 3 consecutive weekly infusions
Interventions/Control_2 Cispatin and docetaxel administered by 3 consecutive weekly infusions
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) histologically or cytologocally proven non-small-cell lung cancer
2) stage IV, or stage III disease ineligible for definitive radiotherapy
3) 70 years or older
4) ECOG PS 0-1
5) Ineligible for standard platinum(bolus infusion)-containing combination chemotherapy
6) No prior chemothrapy(containing gefitinib) for non-small cell lung cancer or other neoplasms
7) No prior surgery within 4weeks before enrollment
8) No prior radiotherapy for primary tumor
9) No prior radiotherapy for metastatic lesions within 2weeks before enrollment
10) Adequate organ function
11) Signed informed consent
Key exclusion criteria 1) Symptomatic brain metastasis
2) Active another neoplams
3) Severe SVC syndrome
4) Massive pericardial, pleural effusion, or ascites
5) Bone metastasis emergent for palliative radiotherapy or surgery
6) Uncontrollable systemic hypertension
7) Heart failure, Unstable angina Myocardial infarction within 6 months
8) Uncontrollable diabetes
9) Active infection
10) Interstitial pneumonia/ Pulmonary fibrosis
11) Hypersensitivity for polysolbate 80
12) Systemic administartion of corticosteroids
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Yokoyama, MD, PhD
Organization Niigata Cancer Center Hospital
Division name Department of internal medicine
Zip code
Address 2-15-3 Kawagishi-cho, Niigata
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Tsukada, MD
Organization JCOG0207 Coordinating Office
Division name Department of internal medicine, Niigata Cancer Center Hospital
Zip code
Address 2-15-3 Kawagishi-cho, Niigata
TEL 025-266-5111
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 NCT00190476
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道がんセンター(北海道)
国立病院機構道北病院(北海道)
山形県立中央病院(山形県)
茨城県立中央病院(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)
国立国際医療センター(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)
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)
近畿中央胸部疾患センター(大阪府)
刀根山病院(大阪府)
大阪市立総合医療センター(大阪府)
兵庫医科大学(兵庫県)
兵庫県立成人病センター(兵庫県)
四国がんセンター(愛媛県)
九州大学医学部附属病院(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 09 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25378648
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
2003 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2003 Year 04 Month 01 Day
Last follow-up date
2007 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
2005 Year 09 Month 09 Day
Last modified on
2014 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000211

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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