UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000032 |
|---|---|
| Receipt number | 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 14:00:59 |
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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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000067
