Head and neck squamous cell carcinoma (HNSCC) MedDRA version: 19.0 Level: PT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [18F]-FAZA
Pharmaceutical Form: Radiopharmaceutical precursor, solution
INN or Proposed INN: [18F]-fluoroazomycin arabinoside
Other descriptive name: [18F]-FAZA
Concentration unit: MBq/m
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients randomized in any of the two arms of EORTC 1219 trial - No contraindication to FAZA-PET/CT: pregnant or breast-feeding woman; for woman subject of childbearing potential, a pregnancy test will be done within 72 hours before the examination. - No contraindication to contrast MRI: = Pregnant woman (pregnancy test will be done within 72 hours before exam) = Patient with metallic implant as vascular clips, cochlear implants or metal foreign body = Patient with cardiac pacemaker or implanted cardioverter-defibrillator = Renal insufficiency (glomerular filtration rate GFR =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - All patient failing one or more of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate FAZA-PET/CT as a prognostic factor of the loco-regional control rate at 2 years in HNSCC patients receiving chemo-radiotherapy ± nimorazole. - Time to locoregional recurrence is counted from the day of randomization to the day of the first record of local or regional progression. Distant recurrence, second cancer and death in absence of locoregional recurrence are not considered events of interest. The follow-up will be done regularly according to a well-defined agenda. ;Secondary Objective: - To evaluate the change in FAZA uptake at day 14 (14 days after starting chemo-radiotherapy treatment relative to baseline), against patient’s outcome measured by loco-regional control rate at 2 years. - To investigate the agreement between FAZA uptake and 15 gene signatures. ;Primary end point(s): - To evaluate FAZA-PET/CT parameters as prognostic factors for the loco-regional control rate at 2 years in HNSCC patients receiving chemo-radiotherapy ± nimorazole. - Time to locoregional recurrence is counted from the day of randomization to the day of the first record of local or regional progression. Distant recurrence, second cancer and death in absence of locoregional recurrence are not considered events of interest. The PET / CT scans objective parameters for hypoxia will be determined within the primary tumor and the pathologic nodes, based on standardized uptake values (SUV), for example: SUVmax, SUVmean, total hypoxic volume x SUVmean. Definition of hypoxia within a tumor on FAZA PET/CT: A hypoxic voxel will be defined as a voxel expressing a SUV equal or above the SUVmean of the posterior contralateral neck muscles plus three standard deviations (Servagi-Vernat S, et al. A prospective clinical study of ¹8F-FAZA PET-CT hypoxia imaging in head and neck squamous cell carcinoma before and during radiation therapy. Eur J Nucl Med Mol Imaging. 2014 Aug;41(8):1544-52.). ;Timepoint(s) of evaluation of this end point: Baseline and 2 weeks after star | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the change in FAZA uptake at day 14 (14 days after starting chemo-radiotherapy treatment relative to baseline), against patient’s outcome measured by loco-regional control rate at 2 years. - To investigate the agreement between FAZA uptake and 15 gene signatures. Definition of response or non-response by repeated scans (pre-/during treatment): In the patients with tumors having a hypoxic volume at baseline, a threshold of hypoxic volume change will be explored to define the response or non-response, based on patient outcomes (loco-regional control rate at year 2). ;Timepoint(s) of evaluation of this end point: After 2 year follow-up. | — |
Countries
Netherlands
Contacts
Public ContactTrialbureau Nuclear Medicine
Radboud University Medical Center
Outcome results
None listed