UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000110 |
|---|---|
| Receipt number | R000000160 |
| Scientific Title | Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2005/09/02 |
| Last modified on | 2015/08/31 15:41:29 |
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Basic information
Public title
Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer
Acronym
Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer
Scientific Title
Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer
Scientific Title:Acronym
Randomized phase II study of carboplatin / gemcitabine versus vinorelbine / gemcitabine in patients with advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Stage IIIb/IV NSCLC
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to compare the efficacy, feasibility, and toxicity profiles of the two
regimens of gemcitabine + carboplatin and gemcitabine + vinorelbine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year survival rate
Key secondary outcomes
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
Patients in group one will receive an infusion of gemcitabine on days 1 and
8. They will also receive an infusion of carboplatin on day 1.
Interventions/Control_2
Patients in
group two will receive infusions of gemcitabine and vinorelbine on days 1
and 8. Treatment in all groups may be repeated every 3 weeks for up to six
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in this trial had histologically or cytologically
confirmed stage IIIb or IV NSCLC. Patients with stage IIIb disease who were
not candidates for thoracic radiation and those with stage IV disease were
eligible, if they had not received previous chemotherapy, had measurable
disease, and had a life expectancy of at least 3 months. Patients who had
received previous radiotherapy were included, if they had assessable disease
outside of the radiation field. Patients with post operative recurrence were
also allowed. Additional entry criteria were age 20-74 years, performance
status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and
adequate bone marrow (leukocyte count > 3,500/mL, neutrophil count >
2,000/mL, hemoglobin concentration > 10.0 g/dL, platelet count > 100,000
/mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase
[AST] and alanine aminotransferase [ALT] < 2.5 times the upper limit of
normal, total bilirubin < 1.5 mg/dL), and pulmonary (PaO2 > 60 torr)
functions.
Key exclusion criteria
Patients were excluded if they had any active concomitant malignancies,
symptomatic brain metastases, prior radiotherapy to the sole site of
measurable disease, past history of severe allergic reactions to drugs,
interstitial pneumonia identified by chest X-ray, liver cirrhosis, superior
vena cava syndrome, or other serious complications, such as uncontrolled
angina pectoris, myocardial infarction within 3 months, heart failure,
uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural
effusion or ascites.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Yamamoto |
Organization
Shizuoka Cancer Center
Division name
Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan
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 | 02 | 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=16804877
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
| 2001 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2004 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2004 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2004 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 02 | 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=R000000160
