Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab

Not Applicable

• Conditions: squamous-cell carcinoma of head and neck

• Registration Number: JPRN-UMIN000011911
• Lead Sponsor: Japanese Oncology Radiation Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-01
• Study Completion: 2019-03-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

1)Previous history of cetuximab treatment before 31th Dec 2012 2)Severe allergic reaction (G3-4) of any component in Erbitax 3) Critical comorbidity otherwise head and neck cancer 4) Second primary cancer except when there has been no evidence of the disease for more than 3 years without any treatment. (Exclude of carcinoma in situ or mucosal cancer which is estimated as stable by local treatment) 5)Positive HbsAg without adequate anti-viral treatment 6) Pregnancy or lactation 7)Any inappropriate reason for registration by physicians

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
One-year progression-free survival One-year overall survival

Secondary Outcome Measures

Name	Time	Method
One-year progression-free survival Proportion of treatment completion Response rate Adverse event rate