UMIN-CTR Clinical Trial

Basic information
Public title	Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Acronym	Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title	Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for patients with advanced non-small cell lung cancer : a prospective randomized phase II study of the Niigata Lung Cancer Treatment Group
Scientific Title:Acronym	Docetaxel,Cisplatin versus Carboplatin,weekly Paclitaxel for 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 (Bi-weekly CDDP, Docetaxel Vs CBDCA, Weekly Paclitaxel)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate, survival
Key secondary outcomes	Progression free survival,safety, toxicity, QOL

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treatment group A: DOC 45mg/m2 day1,15 CDDP 40mg/m2 day1,15
Interventions/Control_2	Treatment group B: PTX 70mg/m2 day1,8,15 CBDCA AUC = 6 day1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients enrolled in this trial had histologically or cytologically confirmed NSCLC who are in-operable or not candidates for thoracic radiation, 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 20=< years, performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, and adequate bone marrow (leukocyte count > 4,000/mm3, <12,000/mm3, neutrophil count>2,000/mm3, hemoglobin concentration > 9.5g/dL, platelet count > 100,000/mm3), 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,infections, 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 6 months,uncontrolled diabetes mellitus or hypertension, uncontrolled massive pleural effusion or ascites.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hirohisa Middle name Last name Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Zip code	951-8510
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 Hirohisa Middle name Last name Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Zip code	951-8510
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	Niigata university Institutional review board
Address	1-757 Asahimachi-dori, Niigata-city, Japan
Tel	025-227-2439
Email	shinki-center@adm.niigata-u.ac.jp

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 04 Month 28 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	80
Results	NA
Results date posted	2019 Year 06 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 05 Month 25 Day
Date of IRB	2004 Year 08 Month 01 Day
Anticipated trial start date	2004 Year 08 Month 01 Day
Last follow-up date	2016 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 04 Month 24 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001378