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)

UMIN ID: C000000079

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: inoperable locally advanced non-small-cell lung cancer
• Date of first enrollment: 2005/09/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): cisplatin and S-1 with concurrent thoracic radiation therapy

Outcome(s)

• Primary Outcome: Phase I: maximum-tolerated doses and the recommended dose for phase II Phase II: Response rate
• Secondary Outcome: Adverse events, overall survival, progression-free survival, pattern of progression/relapse, treatment compliance

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Okayama Lung Cancer Study Group
• Source(s) of Monetary Support: none