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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001244
Receipt No. R000001516
Scientific Title A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503
Date of disclosure of the study information 2008/07/11
Last modified on 2009/01/13

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Basic information
Public title A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503
Acronym A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503
Scientific Title A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503
Scientific Title:Acronym A phase II randomized trial in completely resected Non-Small-Cell Lung Cancer comparing paclitaxel / carboplatin with docetaxel / cisplatin TORG0503
Region
Japan

Condition
Condition Non-Small-Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To select the control arm for the phase III trial in stage IB, II, and IIIA Non-Small-Cell Lung Cancer by comparing docetaxel / cisplatin with paclitaxel / carboplatin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 2-year relapse free survival
Key secondary outcomes Overal survival
Incidence of an adverse event
QOL(FACT-T)
Feasibility

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 A:paclitaxel 200mg/m2 + carboplatin AUC6, day1
q3-4w, 3 courses
Interventions/Control_2 B: docetaxel 60mg/m2 + cisplatin 80mg/m2, day1
q3-4w, 3 courses
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) histologically or cytologically confirmed Non-Small-Cell Lung Cancer
2) completely resected
3) pathological stage IB,IIA,IIB,IIIA(pN0-N2)
4) no prior chemotherapy or radiotherapy
5) performance status of 0-1
6) age 20-70 years old
7) adequate organ function
.WBC >= 4,000 /mm3
.Neutrophil count >= 2,000/mm3
.Platelet count >= 100,000/mm3
.Hemoglobin >= 10g/dL
.AST/ALT within 2.5 times the upper limit of normal (ULN) of institution
.Total serum bilirubin <= 1.5 mg/dL
.Serum creatinine <= 1.5 mg/dL
.Creatinine crearance >=60 ml/min/body
.PaO2 >= 70 torr
8) possible to receive chemotherapy within 4-10 weeks after surgery
9) written informed consent
Key exclusion criteria 1) not recovered from surgical complications
2) active infection such as bacterial infection
3) patients with interstitial pneumonitis or pulmonary fibrosis, as determined by chest CT
4) patients with myocardial infarction within 6 months
5) patients with uncontrolled complications
6) grade 2 or greater peripheral neuropathy
7) active concomitant malignancy
8) pregnant or lactating women
9) past history of allergic reactions to polysorbate 80
10) pneumonectomy
11) bronchoplasty
12) other conditions not suitable for this study
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koshiro Watanabe
Organization Yokohama municipal citizen's hospital
Division name Thoracic Oncology Division
Zip code
Address 56, okazawacho, hotogaya, Yokohama-shi, Kanagawa 240-8555, Japan
TEL 045-331-1961
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kaoru Kubota
Organization National cancer center east
Division name Thoracic Oncology Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-shi, Chiba 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email

Sponsor
Institute Thoracic Oncology Research Group (TORG)
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group (TORG)
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2005 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2013 Year 04 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
2008 Year 07 Month 11 Day
Last modified on
2009 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001516

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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