Trial to Evaluate Radiotherapy With or Without CBDCA in Elderly Patients With Non-Small Cell Lung Cancer (JCOG0301)

Randomized Controlled Trial to Evaluate Standard Thoracic Radiotherapy With or Without Concurrent Daily Low-dose Carboplatine in Elderly Patients With Locally Advanced Non-small Cell Lung Cancer (JCOG0301, NCSLC-Elderly-CBDCA-RT Phase III)

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

The purpose of this study is to evaluate whether radiotherapy with carboplatin will result in longer survival than radiotherapy alone in elderly patients with unresectable stage III NSCLC.

Inclusion Criteria:

• Histologically and/or cytologically proven NSCLC
• Unresectable disease
• Stage IIIA except T3N1M0 and IIIB which does not have disease extended to any contralateral hilar nodes, atelectasis of the entire lung or malignant pleural effusions
• A required radiation field of less than one half of one lung
• Measurable disease
• No previous chemotherapy or radiotherapy
• Age >= 71
• Unable to receive cisplatin-based combination chemotherapy
• ECOG performance status (PS) of 0-2
• Adequate bone marrow, lung, hepatic, and renal function
• Written informed consent

Exclusion Criteria:

• Active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, or severe other comorbidity
• Synchronous cancer or metachronous (within 5 years) malignancy
• Interstitial pneumonia or active lung fibrosis on chest X-ray
• Severe chronic obstructive pulmonary disease, chronic bronchitis, or bronchial asthma
• Pleural or pericardial effusion
• A history of severe hypersensitivity
• Mental disorder
• Judging of inappropriate condition for this study by physician