Phase II study of high-dose thoracic 3D-conformal radiotherapy without elective nodal irradiation concurrently combined with cisplatin and vinorelbine chemotherapy in patients with inoperable stage III non-small cell lung cancer

UMIN ID: UMIN000001743

Registered date:02/03/2009

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: inoperable stage III non-small cell lung cancer
• Date of first enrollment: 2009/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Cisplatin 80mg/m2 on day 1 + vinorelbine 20mg/m2 on days 1 and 8, repeated every 4 weeks for 4 cycles, Thoracic radiotherapy 72 Gy/36 fractions

Outcome(s)

• Primary Outcome: 2-year survival rate
• Secondary Outcome: Response rate, overall survival, incidence of toxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 74years-old
• Gender: Male and Female
• Exclude criteria: 1. malignant pleural or pericardial effusion; 2. contralateral hilar lymph node metastasis, intralobular metastasis or lymphangitis carcinomatosa; 3. serious concomitant medical illness; 4. synchronous active malignancies; 5. history of chemotherapy or thoracic radiotherapy; 6. pregnancy or breast feeding.

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Secondary Sponsor: Hyogo Cancer Center KKR Sapporo Medical Center National Hospital Organization Hokkaido Cancer Center Tochigi Cancer Center
• Source(s) of Monetary Support: none