UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000310
Receipt number R000000400
Scientific Title Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
Date of disclosure of the study information 2006/01/23
Last modified on 2007/03/26 11:26:03

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Basic information

Public title

Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)

Acronym

Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)

Scientific Title

Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)

Scientific Title:Acronym

Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)

Region

Japan


Condition

Condition

Non-small sell lung carcinoma (NSCLC)

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficary of the Docetaxel + Gemcitabin (DG) regimen, and to determine if it is not inferior to the Docetaxel + Cisplatin (DC) regimen.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Survival (1-year survival rate)
Toxicity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The DC arm:
Doc(60mg/m2) day1
CDDP(80mg/m2) day1
Every 3 to 4 weeks

Interventions/Control_2

The DG arm:
Doc(60mg/m2) day8
Gem(800mg/m2) day1,8
Every 3 to 4 weeks

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Histologically or cytologically proven NSCLC
2.Stage IIIB or IV
3.Measurable lesions by RECIST
4.No prior therapy
5.PS(ECOG) 0 or 1
6.Expected survival of more than 3 months
7.Preserved organ functions
8.Age of 20 to 75-year old
9.Written IC

Key exclusion criteria

1.Proven or suspected infections diseases
2.Interstitial pneumonia (pulmonary fibrosis) manifested with chest radiogram and symptoms
3.Uncontrolable complications of heart, liver, DM, bleeding, etc.
4.Peripheral neuropathy of grade 2 or severer
5.Pleural fluid requiring treatment
6.Pericardial fluid
7.Symptomatic brain metastasis
8.Active concomitant malignancy
9.Pregnancy, breast feeding or wish of future bearing
10.History of drug allergy
11.Myocardial infarction within 3 months
12.Requirement of emergency radiotherapy
13.Other conditions not suitable for this study

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisanobu Niitani

Organization

The Tokyo cooperative oncology group

Division name

Chief director

Zip code


Address

1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The Tokyo cooperative oncology group

Division name

Secretariat

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

The Tokyo cooperative oncology group

Institute

Department

Personal name



Funding Source

Organization

The Tokyo cooperative oncology group

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

2006 Year 01 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.jto.org/

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

2002 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2002 Year 05 Month 01 Day

Last follow-up date

2004 Year 08 Month 01 Day

Date of closure to data entry

2004 Year 09 Month 01 Day

Date trial data considered complete

2004 Year 09 Month 01 Day

Date analysis concluded

2004 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 01 Month 23 Day

Last modified on

2007 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name