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

UMIN ID: C000000306

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: 2006/01/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Concurrent chemoradiotherapy Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 60-70Gy/30-35fractions for non-nasopharyngeal cancer, or 1.8Gy/fraction/day, 5fractions/week, total dose of 70.2Gy/39fractions for nasopharyngeal cancer Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses Adjuvant chemotherapy of 2 or more than 2 courses of TPF (CDDP+DOC+5-FU) is scheduled for technically unresectable cases.

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Survival rate, organ preservation 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 and when the disease is superficial 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 Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine
• Source(s) of Monetary Support: Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine