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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000032
Receipt No. R000000067
Scientific Title Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Date of disclosure of the study information 2005/07/28
Last modified on 2014/08/13

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Basic information
Public title Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Acronym Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Scientific Title Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Scientific Title:Acronym Randomized phase II study of the Induction Chemotherapy with Docetaxel alone vs CDDP+Docetaxel for c-stage IB-II Non-Small Cell Lung Cancer (JCOG 0204-MF)
Region
Japan

Condition
Condition pulmonary neoplasm
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of the preoperative Docetaxel and Docetaxel-Cisplatin combination in c-stage IB/II NSCLC, and select the optimal preoperative therapy for phase III trials.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease-free survival rate at 1 year
Key secondary outcomes overall survical, disease-free survival, treatment compliance, response rate to chemotherapy, pathologic CR rate, complete resection rate, post-surgical morbidity/mortality

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
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 Preoperative docetaxel-cisplatin combination chemotherapy
Interventions/Control_2 Preoperative docetaxel monotherapy
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
74 years-old >=
Gender Male and Female
Key inclusion criteria (1)Newly diagnosed, pathologically documented NSCLC
(2)Clinical stage, IB (T2N0M0), IIA (T1N1M0) or IIB (T2N1M0 or T3N0M0)
(3)Age: 15-74 years old
(4)ECOG performance status 0 or 1
(5)Measurable disease
(6)Ample organ function
(7)Signed informed consent
Key exclusion criteria (1) Invasion to the first rib or more superior chest wall
(2) Metastasis to, or involvement of, mediastinal node
(3) Active concomitant malignancy
(4)Unstable angina, recent myocardial infarction, heart failure
(5)Uncontrolled diabetes or hypertension
(6) Pregnant or lactating women
(7)Other severe complications
(8)Systemic use of corticosteroid
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Harubumi Kato, M.D., Ph.D.
Organization International University of Health and Welfare
Division name Research Institute of Health and Welfare Sciences, Graduate School
Zip code
Address 1-3-3 Minamiaoyama, Minato-ku, Tokyo, 107-0062, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideo Kunitoh, M.D.
Organization JCOG0204 Coordinating Office
Division name Department of Respiratory Medicine, Mitsui Memorial Hospital
Zip code
Address 1 Kandaizumi-cho, Chiyoda-ku, Tokyo 101-8643, 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 YES
Study ID_1 NCT00132639
Org. issuing International ID_1 ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東北大学加齢医学研究所(宮城県)
茨城県立中央病院(茨城県)
栃木県立がんセンター(栃木県)
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)
杏林大学医学部(東京都)
東京医科大学(東京都)
癌研究会附属病院(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)
愛知県がんセンター(愛知県)
大阪府立成人病センター(大阪府)
大阪府立羽曳野病院(大阪府)
国立療養所近畿中央病院(大阪府)
大阪市立総合医療センター(大阪府)
兵庫県立成人病センター(兵庫県)
岡山大学医学部(岡山県)
国立病院四国がんセンター(愛媛県)
国立病院九州がんセンター(福岡県)
長崎大学医学部附属病院(長崎県)

Other administrative information
Date of disclosure of the study information
2005 Year 07 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/18728643
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
2002 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2002 Year 10 Month 01 Day
Last follow-up date
2008 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2009 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 07 Month 28 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000067

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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