Phase II study of thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1 for inoperable locally advanced non-small cell lung cancer

UMIN ID: UMIN000002381

Registered date:26/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: inoperable locally advanced stage IIIA/IIIB non-small cell lung cancer
• Date of first enrollment: 2006/01/01
• Target sample size: 65
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): thoracic radiotherapy concurrently combined with cisplatin and vinorelbine chemotherapy followed by sequential therapy with TS-1

Outcome(s)

• Primary Outcome: tumor response
• Secondary Outcome: safety, survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.Infections 2.Apparent interstitial pneumonitis or fibrosis on chest CT 3.Irradiation field larger than half of a ipsilateral lung 4.Ileus 5.Neuropathy (motor, sensory) 6.Severe complications(liver cirrhosis, diabetes mellitus, Clinically significant heart disease, etc.) 7.Myocardial infarction within the last 6 months 8.Another active cancer 9.Pregnancy, intent to become pregnant, or breast-feeding 10.Other non eligible cases judged by investigators

Related Information

• Primary Sponsor: National Hospital Study Group for Lung Cancer
• Source(s) of Monetary Support: National Hospital Study Group for Lung Cancer