Head and neck cancer Head and neck cancer
Conditions
Interventions
Radiation dose escalation of the prescribed dose to the gross tumor volume
(80.5Gy)
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx. - Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated. - Negative for p16 - Locally advanced disease, specifically meeting all following criteria: o Stage III-IV o T-stage 2-4 o All N-stages (N0-3) o M0 - Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin - Eastern Cooperative Oncology Group (ECOG) performance score =18 years - Written informed consent
Exclusion criteria
Exclusion criteria: - Definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies. - Radiation therapy in the head and neck area in the past - No detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost. - Unable or unwilling to give written, informed consent - Contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist. - Unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of dose limiting toxicity (DLT) events, defined as grade *4 mucositis, grade *4 ulceration, grade *4 dermatitis, grade *4 aspiration, grade *4 osteonecrosis and grade >=3 myelopathy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of patients completing radiotherapy regimen (meaning completion of treatment with a maximum of 2 fraction interruption) - Percentage of patients completing the complete chemotherapy regimen - Rates of grade >=3 mucositis, dermatitis, aspiration, dysphagia, hearing impaired, xerostomia, weight loss, trismus, hoarseness, oropharyngeal pain at 6 months after chemoradiation (according to CTCAEv5). - Preliminary tumor response rates measured on the standard follow-up MRI scan - Preliminary disease-free, overall survival and time-weighted locoregional control analyses | — |
Countries
Netherlands
Outcome results
None listed