UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Title of the study (Brief title)	A combination phase II study of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy, toxicity, and survival of gemcitabine with carboplatin for previously untreated elderly non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response Rate(according to RECIST criteria)
Key secondary outcomes	Median survival time, 1-year survival, Adverse events, Time to Progression, Quality of Life

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	The treatment schedule included carboplatin AUC 4 on day 1, and gemcitabine 1000 mg/ m2 on days 1 and 8, every 3 weeks. (Below six courses more than three courses.)
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	1)Patients with histologic or cytologic confirmation of locally advanced or metastatic NSCLC 2)Received either no prior chemotherapy were eligible 3)Measurable lesions 4)Age ≥ 70; 5)Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 6)Adequate organ function 7)Life expectancy for more than 3 months 8)Written informed consent
Key exclusion criteria	1)After thoracic irradiation 2)A case having severe infection and a serious complication 3)Requiring treatment pleural/ascites /pericardial effusion, 4)Interstitial pneumonia or active lung fibrosis on chest X-ray, 5)Symptomatic brain metastases 6)Double cancer 7)Others
Target sample size	40

Research contact person
Name of lead principal investigator	Nobuyuki Katakami
Organization	Institute of Biomedical Research and Innovation
Division name	Department of Translational Research Division of Integrated Oncology
Address	2-2,Minatojima-Minamimachi,Chuo-ku,Kobe 650-0047 Japan
TEL	078-304-5200
Email

Public contact
Name of contact person	Takashi Nishimura
Organization	Kobe City General Hospital
Division name	Respiratory Medicine
Address	4-6,Minatojima-Nakamachi,Chuo-ku,Kobe 650-0046 Japan
TEL	078-302-4321
Homepage URL
Email	t-nishi@kcgh.gr.jp

Sponsor
Institute	Institute of Biomedical Research and Innovation
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	2005 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 12 Month 17 Day
Anticipated trial start date	2005 Year 03 Month 01 Day
Last follow-up date	2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2005 Year 09 Month 08 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000200