In this trial, patients with early squamous cell carcinoma of the tonsil with clinical stage T1-2 (p16-positive or p16-negative) N0-1 (p16-positive)/N0-N2b (p16-negative) according to American Joint Committee on Cancer (AJCC) 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent will be included. The patients will be randomized to in a 1:1 ratio to receive radiotherapy with either photons (conventional radiotherapy) versus radiotherapy with protons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Radiotherapy with either photons or protons.
Gävle Hospital
Gävle, Sweden
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGAcute side effects.
Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored weekly according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Acute radiation morbidity scoring criteria and other side effects are graded according to (Common Toxicity Criteria for Adverse Events (CTCAE) v4.0
Time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.
Late side effects.
Locoregional side effects (mucositis, pain, dysphagia, skin reactions and other functional impairment) are monitored according to a modified morbidity scoring scale based on Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (RTOG/EORTC). Late radiation morbidity scoring criteria and other side effects are graded according to Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.
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Jönköping Hospital
Jönköping, Sweden
RECRUITINGKarlstad Hospital
Karlstad, Sweden
RECRUITINGLinköping University Hospital
Linköping, Sweden
RECRUITINGLund University Hospital
Lund, Sweden
RECRUITINGÖrebro University Hospital
Örebro, Sweden
RECRUITINGKarolinska University Hospital
Stockholm, Sweden
RECRUITINGUniversity Hospital
Umeå, Sweden
RECRUITINGScandion clinic
Uppsala, Sweden
RECRUITING...and 2 more locations