UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001225 |
|---|---|
| Receipt number | 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 10:47:09 |
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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
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
Sponsor or person
Institute
The Japan-multinational Trial Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001490
