UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001244 |
|---|---|
| Receipt number | 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 14:21:00 |
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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
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
Sponsor or person
Institute
Thoracic Oncology Research Group (TORG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001516
