keelkanker oropharyngeal cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients (age >18 yr) with histological proven cT1-2N2-3M0 or cT3-4N0-3M0 p16 negative squamous cell carcinoma of the oropharynx scheduled for radiotherapy in combination with cisplatin, carboplatin or cetuximab that will be treated according to current clinical practice and that are included in the BIO-ROC study.
Exclusion criteria
Exclusion criteria: - Patients with recurrence of previously confirmed head and neck squamous cell carcinoma or other current or previous malignancies in the last 5 years. - Having any physical or mental status that interferes with the informed consent procedure. - Contraindications for MRI (e.g. claustrophobia, arterial clips in central nervous system) - Patients with contraindications for Gadolinium contrast (i.e. hyper-sensitivity for Gadolinium and a poor kidney function)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is locoregional control 2 years after treatment determined by clinical examination. Each primary tumor / node is evaluated separately. The main study parameter is the change in mean diffusion coefficient within the tumor during the first two weeks of treatment measured with MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| IVIM DWI, ctDNA, ex vivo sensitivity characteristics are secondary study parameters. A secondary endpoint is the response of the tumor three months after treatment. | — |
Countries
Netherlands
Outcome results
None listed