Phase II Study of Gemcitabine + S-1 in Elderly Patients With Non-Small Cell Lung Cancer

UMIN ID: UMIN000001032

Registered date:01/04/2008

Basic Information

• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 2008/02/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): gemcitabine, S-1

Outcome(s)

• Primary Outcome: progression-free survival
• Secondary Outcome: compliance, safety, response rate, overall survival time

Key inclusion & exclusion criteria

• Age minimum: 75years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1)No interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray 2)A history of severe allergic reactions to drugs 3) Patients with concurrent serious infections or complications are excluded 4) Clinically significant pleural/pericardial effusion which requires drainage before study entry. 5) Patients with an unstable or serious heart disease 6) Inadequately controlled diabetes mellitus 7) Symptomatic brain metastases 8) The presence of other concomitant or metachronous cancers 9)Any concomitant pathology that would, in the investigator`s opinion, contraindicate the use of the drugs in the protocol

Related Information

• Primary Sponsor: National Hospital Organization Lung Cancer Study Group
• Source(s) of Monetary Support: National Hospital Organization Lung Cancer Study Group