NIPH Clinical Trials Search

UMIN ID: C000000310

Registered date:23/01/2006

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedNon-small sell lung carcinoma (NSCLC)
Date of first enrollment2002/05/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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


Primary OutcomeResponse rate
Secondary OutcomeSurvival (1-year survival rate) Toxicity

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1.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

Related Information


public contact
Address Japan
Affiliation The Tokyo cooperative oncology group Secretariat
scientific contact
Name Hisanobu Niitani
Address 1-23-2 Hamamatsu-cho Minato-ku Tokyo Japan Japan
Affiliation The Tokyo cooperative oncology group Chief director