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Phase I/II study of cisplatin and S-1 with concurrent thoracic radiation therapy for inoperable locally advanced non-small-cell lung cancer (OLCSG 0501)

Phase 1
Conditions
inoperable locally advanced non-small-cell lung cancer
Registration Number
JPRN-C000000079
Lead Sponsor
Okayama Lung Cancer Study Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Not provided

Exclusion Criteria

Involvement of contralateral hilar node, dissemination to pleura/pericardium, or malignant pleural/pericardial effusion Active concomitant malignancy History of chemotherapy or thoracic radiotherapy for previous malignancy Interstitial pneumonia Unstable angina, recent myocardial infarction Uncontrolled diabetes Severe active infection Other severe complications Pregnant or lactating women Judging of inappropriate condition for this study by physician

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Phase I: maximum-tolerated doses and the recommended dose for phase II Phase II: Response rate
Secondary Outcome Measures
NameTimeMethod
Adverse events, overall survival, progression-free survival, pattern of progression/relapse, treatment compliance
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