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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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26 April 2013 |
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Main ID: |
JPRN-C000000310 |
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Date of registration:
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23/01/2006 |
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Primary sponsor: |
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Public title:
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Docetaxel in combination with either cisplatin (DC) or gemcitabine (DG) in unresectable non-small sell lung carcinoma (NSCLC)
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Scientific title:
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Date of first enrolment:
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2002/05/01 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://www.umin.ac.jp/ctr/index.htm |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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Japan |
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Telephone:
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office@tcog.jp |
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Email:
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office@tcog.jp |
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Affiliation:
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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Affiliation:
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The Tokyo cooperative oncology group Secretariat |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
20years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Non-small sell lung carcinoma (NSCLC)
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Intervention(s)
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The DC arm:
Doc(60mg/m2) day1
CDDP(80mg/m2) day1
Every 3 to 4 weeks
The DG arm:
Doc(60mg/m2) day8
Gem(800mg/m2) day1,8
Every 3 to 4 weeks
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Primary Outcome(s)
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Response rate
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Secondary Outcome(s)
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Survival (1-year survival rate)
Toxicity
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Source(s) of Monetary Support
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The Tokyo cooperative oncology group
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