Pathologically confirmed stage IIIA-N2 non-small cell lung cancer
Conditions
Interventions
Bimodality therapy group: two courses of systemic chemotherapy followed by surgeryTrimodality therapy group: two courses of systemic chemotherapy with concurrent thoracic radiotherapy followed by surg
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathological diagnosis of non-small cell lung cancer is necessary. Ipsilateral pathologically-proved mediastinal lymph node with shortest diameter of larger than 1 cm is required.2) Pretreatment lesions are respectable without extranodal invasion. 3) No prior treatment for lung cancer4) Measurable disease5) Age 20 to 70 years6) Performance status (ECOG criteria) 0-17) Adequate organ functions WBC more than 4000/ul, Granulocyte more than 2000/ul, Hg more than 10.0g/dl, Platelet count more than 100,000/ul, T.Bil less than 1.5mg/dl, serum creatinin less than 1.5mg/dl, Creatinine clearlance more than 40mg/dl, PaO2 more than 70torr, Forced expiratory volume in 1 secnd more than 1.5L 8) No prior chemotherapy or radiotherapy for the treatment of other malignancies is essential.9) Written informed consent to participate in the trial is necessary
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Five-year survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed