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A randomized phase II study of cisplatin+TS-1 versus cisplatin+docetaxel, with thoracic radiotherapy for locally advanced non-small cell lung cancer (TORG1018)

Phase 2
Conditions
on-small cell lung cancer
Registration Number
JPRN-UMIN000005993
Lead Sponsor
Thoracic Oncology Research Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
110
Inclusion Criteria

Not provided

Exclusion Criteria

1)T3N1 2)SVC syndrome with difficulty of a lot of intravenous infusion 3)clinically significant contralateral hilar lymph node metastasis, carcinomatous pericardial or pleural effusion, or carcinomatous lymphangitis 4)concurent serious infection or complications 5)continuous watery diarrhea 6)significant interstitial pneumonitis or pulmonary fibrosis in chest CT 7)concomitant cancers within 5 years 8)concomitant therapy with another new anticancer drug, phenytoin, warfarin or flucytocine 9)inadequately controlled diabetes mellitus 10)HBs Ag is positive 11)a history of serious drug allergy 12)mental disease or psychotic manifestation 13)pregnancy, breast feeding, wish of future bearing or hesitation in contraception 14)other conditions not suitable for this study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2 year survival rate
Secondary Outcome Measures
NameTimeMethod
over all survival, progression free survival, adverse events, dose intensity
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