UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Title of the study (Brief title)	Gemcitabine versus gemcitabine-carboplatin for elderly patients with advanced non-small cell lung cancer : a prospective randomized 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 vs 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	Progression free survival,safety, toxicity, QOL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients in group A will receive an infusion of gemcitabine on days 1 and 8.
Interventions/Control_2	Patients in group B will receive an infusion of gemcitabine on days 1 and 8. They will also receive an infusion of carboplatin on day 8.
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	60

Research contact person
Name of lead principal investigator	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
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	Hirohisa Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2007 Year 10 Month 25 Day
Anticipated trial start date	2007 Year 11 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000001327