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

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 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


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

Value
https://center6.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