Early response evaluation of proton therapy by PET-imaging in squamous cell carcinoma located in the head and neck
Recruiting
- Conditions
- 'head-and-neck cancer''head-and-neck squamous cell carcinoma'10027655
- Registration Number
- NL-OMON52797
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
protocol inclusion criteria (paragraph 4.2.1).
- adult
- primary untreated head-and-neck squamous cell carcinoma
- measurable lesion of at least 2 cm diameter
- eligible for protontherapy ± chemotherapy at HollandPTC
- expected life expectancy at least 3 months
Exclusion Criteria
protocol exclusion criteria (paragraph 4.2.2).
- known metastases
- paranasal sinus, salivary or thyroid cancer
- prior chemotherapy or radiotherapy within last 3 years
- resected disease
- concurrent malignancies
- uncontrolled diabetes mellitus
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The main study parameters are the percent<br /><br>change in hypoxic tumour volume between baseline PET and interim PET of<br /><br>hypoxia. The primary endpoint is 3-year local recurrence-free survival (LRFS).<br /><br><br /><br>Intervention: All patients are asked to undergo one additional baseline<br /><br>18F-FAZA PET-scan (hypoxia) at baseline 18F-FDG PET-imaging (glucose<br /><br>metabolism) is already performed during clinical work-up. Both 18F-FAZA and<br /><br>18F-FDG PET-scans will be repeated in the (end of the) second week of PT,<br /><br>unless no hypoxia is witnessed at baseline, then only the 18F-FDG PET-scan is<br /><br>repeated. In a pilot setting, 10 patients are asked to further undergo<br /><br>activation PET-scanning immediately after PT in the first, second and last<br /><br>week.</p><br>
- Secondary Outcome Measures
Name Time Method