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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001225
Receipt No. R000001490
Scientific Title Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Date of disclosure of the study information 2008/07/01
Last modified on 2014/01/31

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Basic information
Public title Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Acronym Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Scientific Title Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Scientific Title:Acronym Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.
Region
Japan

Condition
Condition Stage IIIB/IV non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This phase II study is planned to obtain evidence for docetaxel and carboplatin as first-line treatment of Japanese patients with stage IIIB-IV NSCLC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival (PFS)
Key secondary outcomes Response rate, 1-yr survival, overall survival, safety

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 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 docetaxel 60mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1
q3w, 6 cycles
Interventions/Control_2 paclitaxel 200mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1
q3w, 6 cycles
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)written informed consent
2)histologically or cytologically confirmed stage IIIB (inoperable or ineligible for curative radiation therapy) or IV NSCLC with no prior chemotherapy. Recurrence after surgery is categorized as stage IV.
3)At least 3 weeks passed and recovered from toxicity from prior radiation therapy or surgery if applicable.
4)Measurable disease.
5)ECOG Performance status 0 or 1.
6)Adequate organ function
(1) Neutrophil count >= 2,000/mm3
(2) Platelet count >= 100,000/mm3
(3) Hemoglobin >= 9.0g/dL
(4) AST/ALT within twice the upper limit of normal (ULN) of institution
(5) Total bilirubin within the ULN
(6) Serum creatinine within the ULN (enzyme method)
(7) Creatinine clearance >= 50 mL/min
7)PaO2 >= 70 torr or SpO2 >= 94% (room air)
8)Estimated life expectancy longer than 3 months
Key exclusion criteria 1)Patients with serious infections or suspected infections with fever.
2)Pregnant or lactating women
3)Active concomitant malignancy
4)Past history of allergic reactions to polysorbate 80
5)Patients with interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray
6)Patients with inadequately controlled complications such as hypertension, congestive heart failure, myocardial infarction, arrhythmia, bleeding and diabetes.
7)Clinically significant pleural/pericardial effusion which requires treatment
8)Symptomatic brain metastases
9)Grade 2 or greater peripheral neuropathy
10)Patients judged by the investigator as unfit to be enrolled in the study
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki KAWAHARA
Organization Federation of National Public Sevice Personnel Mutual Aid Associations
Otemae Hospital
Division name Medical Oncology
Zip code
Address 1_5_34 Otemae, chuo_ku, Osaka
TEL 06-6941-0484
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Japan-multinational Trial Organization
Division name The Japan-multinational Trial Organization
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute The Japan-multinational Trial Organization
Institute
Department

Funding Source
Organization The Japan-multinational Trial Organization
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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results 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
2007 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 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 06 Month 30 Day
Last modified on
2014 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001490

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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