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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Carboplatin

Criteria

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