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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000110
Receipt No. 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

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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
Email

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
Email datacenter@wjog.jp

Sponsor
Institute West Japan Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000160

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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