UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000147
Receipt number R000000210
Scientific Title A Randomized phase II study of docetaxel versus weekly carboplatin and CPT-11 for previously treated Non-Small cell lung cancer
Date of disclosure of the study information 2005/09/09
Last modified on 2008/05/28 10:36:29

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Basic information

Public title

A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer

Acronym

A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer

Scientific Title

A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer

Scientific Title:Acronym

A Randomized phase II study of docetaxel versus weekly
carboplatin and CPT-11
for previously treated Non-Small cell lung cancer

Region

Japan


Condition

Condition

second line chemotherapy for Non-Small cell lung cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of carboplatin/irinotecan combination to docetaxel
as second line chemotherapy for non-small cell lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Primary endpoint:Response rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

carboplatin/irinotecan combination

Interventions/Control_2

docetaxel

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

non-small cell lung cancer
stage 3B or 4
life expectancy at least 3 month
age 75 or younger
PS 0-2
Adequate renal, liver and bone marrow function
PaO2 65 torr or more

Key exclusion criteria

patient who received docetaxel or irinotecan

Target sample size

64


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kyoichi Okishio

Organization

National Hospital Organization Kinki-chuo chest medical center

Division name

Respiratory Medicine

Zip code


Address

1180 Nagasone Sakai, JAPAN

TEL

072-250-4034

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kyoichi Okishio

Organization

National Hospital Organization Kinki-chuo chest medical center

Division name

Respiratory Medicine

Zip code


Address

1180 Nagasone Sakai, JAPAN

TEL

072-250-4034

Homepage URL


Email



Sponsor or person

Institute

West Japan Oncology Group

Institute

Department

Personal name



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


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

2005 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

1997 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

1997 Year 07 Month 01 Day

Last follow-up date

1999 Year 01 Month 01 Day

Date of closure to data entry

1999 Year 01 Month 01 Day

Date trial data considered complete

1999 Year 01 Month 01 Day

Date analysis concluded

1999 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2005 Year 09 Month 09 Day

Last modified on

2008 Year 05 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000210


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name