UMIN-CTR Clinical Trial

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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