Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study

UMIN ID: C000000273

Registered date:01/03/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Head and neck squamous cell carcinoma at stage III and IV
• Date of first enrollment: 2004/03/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 60Gy/30fractions/6weeks Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses Adjuvant chemotherapy is scheduled for patients with unresectable disease.

Outcome(s)

• Primary Outcome: Survival rate
• Secondary Outcome: Response rate, safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT 2) major heart/lung disorders, or uncontrolled diabetes mellitus 3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment 4) major pulmonary effusion or ascites 5) neuropathy or edema 6) pregnancy or lactation 7) history of major allergy to medicine 8) long use of steroid

Related Information

• Primary Sponsor: Department of Otolaryngology, Osaka University School of Medicine
• Source(s) of Monetary Support: none