Postoperative Accelerated RadioTherapy versus conventional radiotherapy in squamous cell head and neck cancer (POPART). A phase III randomised study.
Recruiting
- Conditions
- Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- Registration Number
- NL-OMON21364
- Lead Sponsor
- VU University Medical Center / Groningen University Medical CenterComprehensive Cancer Center Amsterdam (IKA)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
Inclusion Criteria
1. Proper clinical evaluation must have been performed according to the national guidelines;
2. Histologically proven squamous cell carcinoma (WHO grade 1-3) of the oral cavity, oropharynx, hypopharynx or larynx (unknown primary excluded);
Exclusion Criteria
1. Macroscopic residual disease at the primary site and/or neck;
2. Distant metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method oco-regional control.
- Secondary Outcome Measures
Name Time Method 1. Distant metastases; <br /><br>2. Disease free survival; <br /><br>3. Overall survival; <br /><br>4. Quality of life; <br /><br>5. Acute morbidity, <br /><br>6. Late morbidity; <br /><br>7. Cost-effectiveness.