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

Not Applicable
Conditions
Head and neck squamous cell carcinoma at stage III and IV
Registration Number
JPRN-C000000306
Lead Sponsor
Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine
Brief Summary

CR rate 71%, 2-year overall survival 82%, and 4-year overall survival 68% for technically resectable disease. CR rate 45%, 2-year overall survival 58%, and 4-year overall survival 44% for technically unresectable disease.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
150
Inclusion Criteria

Not provided

Exclusion 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate
Secondary Outcome Measures
NameTimeMethod
Survival rate, organ preservation rate, safety
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