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UMIN ID:

Recruitment status
Unique ID issued by UMIN C000000112
Receipt No. R000000164
Scientific Title Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Date of disclosure of the study information 2005/09/04
Last modified on 2005/09/04

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Basic information
Public title Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Acronym Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Scientific Title Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Scientific Title:Acronym Phase II study of carboplatin-gemcitabine combination chemotherapy in elderly patients with advanced non–small cell lung cancer
Region
Japan

Condition
Condition non small cell lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of carboplatin and gemcitabine in elderly patients with advanced non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 day 1: CBDCA 4AUC GEM 1000mg/m2
day 8: GEM 1000mg/m2
Interventions/Control_2
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 Patients with histologically or cytologically confirmed NSCLC who were 70 years or older at diagnosis, had measurable disease on thoracic computed tomography (CT) scans, and had not previously received chemotherapy were eligible for enrollment in the study. An additional requirement was that the disease was inoperable as a result of substantial comorbidity, impairment of respiratory function, or anatomic contraindication. Patients who relapsed after complete tumor resection or in whom resection was incomplete were also eligible. Further entry criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as well as adequate bone marrow (leukocyte count, 4000 to 12,000/µL; hemoglobin concentration, >9.0 g/dL; platelet count, >100,000/µL), renal (serum creatinine concentration, <1.5 mg/dL), hepatic (serum aspartate aminotransferase and alanine aminotransferase , <1.5 times the upper limit of the normal range; serum total bilirubin, <1.5 mg/dL), and pulmonary (PaO2, >70 torr) function.
Key exclusion criteria Individuals with active infection, severe heart disease, active concomitant malignancy, or pleural or pericardial effusion requiring drainage were excluded.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isamu Okamoto
Organization Kinki University School of Medicine
Division name Department of Medical Oncology,
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ji-ichiro Sasaki
Organization Kumamoto University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email saji@gpo.kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University School of Medicine
Institute
Department

Funding Source
Organization Kumamoto University School of Medicine
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 04 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
Date of protocol fixation
2004 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2006 Year 10 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
2005 Year 09 Month 04 Day
Last modified on
2005 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000164

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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