Primary Non-operated Squamous Cell Carcinoma of Hypopharynx, Primary Non-operated Squamous Cell Carcinoma of Larynx, Primary Non-operated Squamous Cell Carcinoma of Oral Cavity, Primary Non-operated Squamous Cell Carcinoma of Oropharynx
Conditions
Brief summary
The investigators hypothesize that treatment adaptation to biological and anatomical changes, occurring during treatment, can increase the chance of cure at minimized or equal radiation-induced toxicity in head and neck cancer patients. This trial compares standard intensity-modulated radiotherapy (IMRT), using only pre-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography to adaptive 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography voxel intensity based IMRT or volumetric-modulated arc therapy (VMAT) using repetitive per-treatment planning 18F-2-fluoro-2-deoxy-D-glucose positron emission tomography for head and neck cancer.
Interventions
RADIATIONAdaptive dose-painting-by-numbers
Adaptive dose escalation by dose-painting-by-numbers.
RADIATIONstandard intensity-modulated radiotherapy (IMRT)
Standard radiotherapy for head and neck cancer.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx * Primary unresectable tumor and/or patients that refused surgery * Stages T1-4; T3-4 N0 or T(any) N1-3 for glottic cancer * Multidisciplinary decision of curative radiotherapy or radiochemotherapy * Karnofsky performance status \>= 70 % * Age \>= 18 years old * Informed consent obtained, signed and dated before specific protocol procedures
Exclusion criteria
* High risk Human Papilloma Virus (HPV) * Treatment combined with brachytherapy * Prior irradiation to the head and neck region * History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years. * Distant metastases * Pregnant or lactating women * Creatinine clearance (Cockcroft-Gault) =\< 60 mL/min * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To obtain 25 % increase in local control at 1 year with adaptive dose escalation comparing to standard treatment. | at 1 year | 18F-FDG-PET/CT scans will be performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Topography of local and/or regional relapse. | during the first year post-treatment | 18F-FDG-PET/CT scans will be performed during the first year post-treatment time point of local and/or regional relapse |
| Tumor response | 3 months post-treatment | 18F-FDG-PET/CT scans will be performed |
| Acute toxicity | up to 12 months of follow-up | — |
| Regional (elective neck) and distant control. | after 1 year | 18F-FDG-PET/CT scans will be performed. |
| Late toxicity | up to 12 months of follow-up | — |
| Time point of local and/or regional relapse. | during the first year post-treatment | 18F-FDG-PET/CT scans will be performed. |
| Overall disease-specific, disease-free survival. | at 1 year | — |
Countries
Belgium
Outcome results
None listed