Multi-institutional Phase IIa Trial of Postoperative Chemoradiotherapy in High Risk Patients with Head and Neck Squamous Cell Carcinoma
Phase 2
- Conditions
- Head and neck squamous cell carcinoma
- Registration Number
- JPRN-jRCTs051210100
- Lead Sponsor
- Mizowaki Takashi
- Brief Summary
Postoperative chemoradiotherapy using hyperfractionation in IMRT was feasible for high-risk patients with head and neck squamous cell carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
1. Tumor histology is confirmed as squamous cell carcinoma by surgically resected specimen.
2. Patients with oral, oropharyngeal, hypopharyngeal, or laryngeal carcinoma.
3. Patients detected either or both of i) and ii) by primary tumor resection and neck dissection.
i) Positive microscopic excisional margin.
ii) Extracapsular extension of cervical lymph node.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Exclusion Criteria
Patients with p16 positive oropharyngeal carcinoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Completion rate of treatment
- Secondary Outcome Measures
Name Time Method Grade 3 or higher non-hematological acute adverse event rate<br>Rate of laryngeal edema requiring urgent intervention such as tracheotomy or intubation<br>Severe adverse event rate