UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001131
Receipt No. R000001376
Scientific Title Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group
Date of disclosure of the study information 2008/05/01
Last modified on 2018/06/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group
Acronym Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title:Acronym Gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a phase II study of the Niigata Lung Cancer Treatment Group
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the response rate of elderly non-small cell lung cancer with chemotherapy (CBDCA+GEM)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Safety,survival,toxicity, QOL

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 Patients will receive an infusion of gemcitabine on days 1 and
8. They will also receive an infusion of carboplatin on day 8.
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 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. Additional entry criteria were age 75=< years, performance
status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and
adequate bone marrow (leukocyte count > 4,000/mL, neutrophil count >
2,000/mL, hemoglobin concentration > 9.5g/dL, platelet count > 100,000
/mL), kidney (creatinine < 1.2 mg/dL), liver (aspartate aminotransferase
[AST] and alanine aminotransferase [ALT] < 100, total bilirubin < 2.0 mg/dL), and pulmonary (PaO2 > 60 torr)
functions.
Key exclusion criteria Patients were excluded if they had any active concomitant malignancies,
symptomatic brain metastases, past history of severe allergic reactions to drugs,
interstitial pneumonia identified by chest X-ray, 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 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Email hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohisa Yoshizawa
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Research Center
Zip code
Address 1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL 025-227-2517
Homepage URL
Email hy0522@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment 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
2008 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2004 Year 06 Month 04 Day
Date of IRB
Anticipated trial start date
2004 Year 09 Month 01 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 10 Month 01 Day
Date trial data considered complete
2008 Year 10 Month 01 Day
Date analysis concluded
2008 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 04 Month 24 Day
Last modified on
2018 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001376

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.