Oropharyngeal cancer
Conditions
Interventions
None
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible participating in this study, patients must meet all the following criteria: • Clinical diagnosis of squamous cell carcinoma of the oropharynx, with or without histological confirmation • In case of already histology-confirmed oropharyngeal cancer - primary tumor accessible for re-sampling without general anaesthesia • Eligible for curative treatment with radiotherapy with or without the addition of systemic agents • Written informed consent obtained • Age >= 18 years
Exclusion criteria
Exclusion criteria: The following patients are not eligible for participation in this study: • Patients with histology-confirmed oropharyngeal cancer, safely accessible for re-sampling only under general anaesthesia • Patients currently under treatment for other malignant disease (unless basal cell carcinoma of the skin) • Previous radiotherapy in the head and neck area (with overlapping RT area) • Recurrent oropharyngeal cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint of this study is establishing the relation between the ex vivo radiosensitivity assay and clinical evaluation by physical examination (and MRI imaging, if indicated), at three months after treatment in the complete group of OPC patients included in this study. In the ex vivo radiosensitivity assay, the percentage of surviving tumor cells after irradiation (relative to untreated control) is determined. This continuous variable will be related to a categorical outcome of clinical (and radiological, if indicated) evaluation of tumor response, namely: complete response, residual disease or uncertain. | — |
Secondary
| Measure | Time frame |
|---|---|
| - establishing the above mentioned relation in various treatment groups (radiation only, chemo-radiotherapy, bioradiation with cetuximab, radiotherapy with protons instead of photons); - determining the effect known prognostic factors for head-and-neck SCC (smoking, HPV-status, age, comorbidities) on the above mentioned relation; - establishing if the relation of ex vivo radiosensitivity assay with the locoregional tumor control of OPC patients treated with (chemo/bio-)radiotherapy at 2 years after treatment. Clinical evaluation will be performed as described in 5.1.1; - determining the prognostic value, specificity and sensitivity of ctDNA as biomarkers of treatment response (for the subgroup of patients that also participate in the COMPLETE study protocol); - building a repository of tumor biopsies and blood samples of OPC patients for future testing and validation of new (combinations of) biomarkers to predict treatment outcomes. | — |
Contacts
Public ContactMarta Capala
Erasmus MC
Outcome results
None listed