'head-and-neck cancer' 'head-and-neck squamous cell carcinoma'
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main study parameters are the percent change in hypoxic tumour volume between baseline PET and interim PET of hypoxia. The primary endpoint is 3-year local recurrence-free survival (LRFS). Intervention: All patients are asked to undergo one additional baseline 18F-FAZA PET-scan (hypoxia) at baseline 18F-FDG PET-imaging (glucose metabolism) is already performed during clinical work-up. Both 18F-FAZA and 18F-FDG PET-scans will be repeated in the (end of the) second week of PT, unless no hypoxia is witnessed at baseline, then only the 18F-FDG PET-scan is repeated. In a pilot setting, 10 patients are asked to further undergo activation PET-scanning immediately after PT in the first, second and last week. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether early changes in glucose metabolism between baseline and the second week of PT are predictive for time-to-local recurrence after PT for HNSCC. To assess independent predictive value of, and preference for either (baseline, interim or changes in) hypoxia-PET or PET of glucose metabolism (in whom and when); To assess spatial conformity of recurrences with PET-identified radioresistant areas (where) in relation to planning dose and accuracy of dose-delivery; To perform adaptive replanning based on two-timepoint PET and determine the expected dose to tumour and normal tissues for each PET technique; To assess spatial conformity of treatment plan and dose-delivery determined by activation PET using a clinical scanner (quality assurance); To determine tissue-changes during PT measured by activation PET and relate these to the study endpoint and PET of glucose metabolism and hypoxia. | — |
Countries
Netherlands
Outcome results
None listed