A phase III trial comparing preoperative chemotherapy to chemoradiotherapy before surgery in patients with pathologically-confirmed stage IIIA-N2 non-small cell lung cancer.

UMIN ID: C000000174

Registered date:14/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pathologically confirmed stage IIIA-N2 non-small cell lung cancer
• Date of first enrollment: 2001/01/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Bimodality therapy group: two courses of systemic chemotherapy followed by surgeryTrimodality therapy group: two courses of systemic chemotherapy with concurrent thoracic radiotherapy followed by surgeryChemotherapy regimen consists of carboplatin and docetaxel on day 1. Two courses of chemotherapy with 3 weeks interval is plannedPatients undergo surgery 3 to 4 weeks after the end of second course of chemotherapy.
Radiotherapy begins on day 1, concurrently with chemotherapy.(The total dose of radiation is 40 Gy, 2 Gy/fraction/day)

Outcome(s)

• Primary Outcome: Five-year survival
• Secondary Outcome: toxicity of a preoperative treatment and a response rate, resection rate, complete resection rate, unresectable rate, downstaging rate, postoperative mortality and morbidity, hospital mortality, disease-free survival rate, median survival time, pattern of recurrence (first site of relapse)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1)Active double cancer. The definition of inactive is that disease-free interval is more than 5 years. However, patients who have history of completely resected early gastric cancer,uterine cervical cancer, completely resected skin malignancies (except malignant melanoma)are acceptable. 2)Uncontrollable angina or myocardial infarction within the past 3 months. Severe heart disease, arrhythmia requiring treatment. 3)Uncontrollable hypertension and Diabetes Mellitus. 4)Patients with severe COPD (FEV1.0percent less than 65)or pulmonary fibrosis recognized with computed tomography scanning. 5)Weight loss more than 10 percent within the past 6 months 6)Women during pregnancy or lactating. 7)ther unsuitable patient judged by a physician.

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None