UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000117 |
|---|---|
| Receipt number | R000000169 |
| Scientific Title | Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2005/09/06 |
| Last modified on | 2015/08/31 15:46:50 |
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Basic information
Public title
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer
Acronym
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer
Scientific Title
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Phase 3 study of docetaxel vs vinorelbine in elderly patients with advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
elderly patients with advanced non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced NSCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
safety,efficacy,QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
docetaxel 60 mg/m2 on day 1,repeated every 21 days over four cycles
Interventions/Control_2
vinorelbine 25 mg/m2 on days 1and 8, repeated every 21 days over four cycles.
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
Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were over 70 years old with measurable or assessable disease were eligible for this trial.They had to have a life expectancy of at least 3 months.Additional entry criteria were as follows:(a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale;(b) adequate function of bone marrow , kidney , liver .
Key exclusion criteria
Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or asites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinzoh Kudoh, MD |
Organization
Osaka City University Medical School
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, Japan, 545-8585
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Nakamura |
Organization
West Japan Oncology Group
Division name
WJOG datacenter
Zip code
Address
TEL
06-6633-7400
Homepage URL
datacenter@wjog.jp
Sponsor or person
Institute
West Japan Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2005 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed?term=16877734
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
Completed
Date of protocol fixation
| 2000 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2000 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 06 | Day |
Last modified on
| 2015 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000169
