WJOG7512L:A randomized phase III study of maintenance therapy with TS-1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus TS-1 for advanced or relapsed squamous cell carcinoma of the lung

UMIN ID: UMIN000010396

Registered date:02/04/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced or relapsed squamous cell carcinoma of the lung
• Date of first enrollment: 2013/05/13
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

TS-1 after induction therapy with carboplatin plus TS-1
Best supportive care after induction therapy with carboplatin plus TS-1

Outcome(s)

• Primary Outcome: Progression free survival from the date of randomization for maintenance therapy
• Secondary Outcome: Overall survival, QOL and adverse events from the date of randomization for maintenance therapy, Progression free survival and overall survival from the date of enrollment

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Induction therapy 1) SVC syndrome 2) Clinically significant drug allergy 3) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment 4) Have received radiation therapy or surgery to lesions of lung 5) Patient received palliative radiotherapy except to the primary lesion in last 2 weeks. 6) With severe infection, bleeding, cardiac diseases. 7) With continues diarrhea 8) Ileus or sub-ileus 9) With interstitial pneumonia, sever COPD 10) Symptomatic brain metastasis 11) Presence of other active malignancy 12) Un-controlled DM 13) Uncontrolled psychiatric disease. 14) pregnancy or lactating patients 15) Positive serum HBs antigen 16) Others

Related Information

• Primary Sponsor: West Japan Oncology Group
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.