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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001132
Receipt No. R000001378
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
Date of disclosure of the study information 2008/04/28
Last modified on 2019/06/21

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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/ctr_e/ctr_view.cgi?recptno=R000001378

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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