A Phase I/II Study of Carboplatin and TS-1 in Patients with Advanced Non-small Cell Lung Cancer: CJLSG-0402

UMIN ID: C000000234

Registered date:24/11/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Advanced non-small cell lung cancer
• Date of first enrollment: 2005/02/01
• Target sample size: 32
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Carboplatin and TS-1 chemotherapy

Outcome(s)

• Primary Outcome: Phase I: Safety, maximum tolerated doses, recommended doses Phase II: Response rate
• Secondary Outcome: Phase I: Response rate Phase II: Safety, survival time

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Massive pleural effusion with the incication of local therapy 2. Clinically appearent pericardial effusion 3. Serious medical complications: Uncontrolled angina pectoris, myocardial infarction within 3 months, heart failure. Uncontrolled diabetes mellitus, hypertension, infections. Contraindication for carboplatin or TS-1 use 4. Pulmonary fiblosis detectable on chest X-ray films 5. Pregnant or milk-feeding female. Intention to be pregnant in the future 6. Other clinical difficulites to this study

Related Information

• Primary Sponsor: Central Japan Lung Study Group
• Source(s) of Monetary Support: Central Japan Lung Study Group