A combination phase II study of gemcitabine and S-1 for platinum-refractory patients with non-small cell lung cancer (TORG 0705)

UMIN ID: UMIN000000896

Registered date:01/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 2007/11/01
• Target sample size: 32
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Chemotherapy S-1 (60 mg/m2, days 1-14, every 3 weeks) Gemcitabine (1,000 mg/m2, days 8 and 15, every 3 weeks) at least 3 courses, until reaching PD

Outcome(s)

• Primary Outcome: Overall response rate
• Secondary Outcome: Toxicity, Overall survival, Progression free survival, Subset analyses

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Any contraindication for S-1 or gemcitabine. 2) Active concomitant malignancy. 3) Active infectious diseases. 4) Prior resection of primary tumor. 5) Interstitial pneumonia obviously presented by x-ray and/or clinical manifestations. 6) Experience of any pulmonary event during the previous chemotherapy. 7) Prior chemotherapy including any primidine analogue such as 5-FU, tegafur, UFT, S-1, capecitabine, gemcitabine and Ara-C. 8) Brain metastasis with symptoms or requirement of treatment. 9) Requirement of thoracic irradiation. 10) Pleural effusion, ascites or pericardial effusion requiring treatment. 11) Serious abnormalty in ECG. 12) Uncontrolled diabetes mellitus. 13) Women in regnancy, potential pregnancy, or breast feeding. Men willing to cause pregnancy. 14) Other inadequate conditions .

Related Information

• Primary Sponsor: Thoracic Oncology Research Group
• Source(s) of Monetary Support: None
• Secondary ID(s): TORG0705