A Phase II Study of Combination Chemotherapy using TS-1 and Cisplatin with Concurrent Thoracic Radiotherapy for Locally Advanced Non-Small Cell Lung Cancer

UMIN ID: UMIN000001370

Registered date:12/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Locally Advanced Non-Small Cell Lung Cancer
• Date of first enrollment: 2006/11/01
• Target sample size: 55
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Cisplatin+TS-1

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Toxicity, overall survival, progression free survival, the rate of treatment success, The comparison of monitor units at the reference points with or without inhomogeneity corrections.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1.with Superior vena cava syndrome 2.with sever allergy 3.on going other studies or treating with uncomfortable drugs to TS-1 and cisplatin 4.contra hilar lymph nod swelling, pleural or cardiac effusion dew to cancer, lymphangitis carcinomatoses, T3N1M0 5.with sever infection, bleeding, cardiac diseases. 6.with continues diarrhea 7.ileus or sub-ireus 8.with interstitial pneumonia, sever COPD 9.Presence of other active malignancy 10.un-controlled DM 11.Uncontrolled psychiatric disease. 12.pregnancy or lactating patients 13.Others

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: None