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)

UMIN ID: C000000060

Registered date:15/08/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell Lung Cancer
• Date of first enrollment: 2003/09/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Radiotherapy alone
CBDCA and Radiotherapy

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: Response rate, Adverse events, Progression-free survival, Pattern of progression/relapse

Key inclusion & exclusion criteria

• Age minimum: 71years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) active infection, diarrhea, ileus, uncontrolled diabetes, myocardial infarction within three months, severe other comorbity, (2) synchronous cancer or metachronous (within 5 years) malignancy, (3) interstitial pneumonia or active lung fibrosis on chest X-ray, (4) severe chronic obstructive pulmonary disease, chronic bronchitis, bronchial asthma, (5) pleural or pericardial effusion, (6) a history of severe hypersensitivity, (7) mental disorder, (8) judging of inappropriate condition for this study by physician.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00132665