A prospective, explorative cohort study to assess the value of an ex vivo radiosensitivity assay as a BIOmarker of treatment Response in Oropharyngeal Cancer (BIO-ROC).
Recruiting
- Conditions
- 10027655oropharyngeal cancerthroat cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion 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
- Patients with histology-confirmed oropharyngeal cancer, only 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Esablishing the relation and the manner of the relation between the ex vivo<br /><br>functional assay for tumor radiosensitivity with clinical tumor response of OPC<br /><br>patients treated with (chemo/bio-)radiotherapy at 3 months after treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- establishing the above mentioned relation in various treatment groups (such<br /><br>as: radiation only, chemo-radiotherapy, bioradiation with cetuximab,<br /><br>radiotherapy with protons instead of fotons)<br /><br>- describing the effect of known prognostic factors (smoking, HPV-status, age,<br /><br>comorbidities) on the above mentioned relation<br /><br>- establishing the relation of the of ex vivo functional assay for tumor<br /><br>radiosensitivity with locoregional tumor control of OPC patients treated with<br /><br>(chemo/bio-)radiotherapy at 2 years after treatment<br /><br>- establishing the prognostic value, specificity and sensitivity of ctDNA as<br /><br>biomarkers of treatment response<br /><br>- including every study patient in a repository of tumor biopsies and blood<br /><br>samples for future testing and validation of new (combinations of) biomarkers<br /><br>to predict treatment outcomes</p><br>