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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy delivered with photons | Active Comparator |
| |
| Radiotherapy delivered with protons | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Radiotherapy with either photons or protons. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute 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 | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Gebre-Medhin, MD | Contact | +46 46 17 75 20 | maria.gebre-medhin@skane.se | |
| Iréne Schönström, RN | Contact | +46 46 17 85 59 | irene.schonstrom@skane.se |
| Name | Affiliation | Role |
|---|---|---|
| Maria Gebre-Medhin, MD | Lund University Hospiyal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gävle Hospital | Recruiting | Gävle | SE-803 24 | Sweden |
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| ID | Term |
|---|---|
| D014067 | Tonsillar Neoplasms |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sahlgrenska University Hospital | Recruiting | Gothenburg | SE-413 46 | Sweden |
|
| Jönköping Hospital | Recruiting | Jönköping | SE-553 05 | Sweden |
|
| Karlstad Hospital | Recruiting | Karlstad | SE-652 30 | Sweden |
|
| Linköping University Hospital | Recruiting | Linköping | SE-587 50 | Sweden |
|
| Lund University Hospital | Recruiting | Lund | SE-221 85 | Sweden |
|
| Örebro University Hospital | Recruiting | Örebro | SE-703 82 | Sweden |
|
| Karolinska University Hospital | Recruiting | Stockholm | SE-171 64 | Sweden |
|
| University Hospital | Recruiting | Umeå | SE-907 37 | Sweden |
|
| Scandion clinic | Recruiting | Uppsala | SE-752 37 | Sweden |
|
| Uppsala Accademical Hospital | Recruiting | Uppsala | SE-753 09 | Sweden |
|
| Västmanlands Hospital | Recruiting | Västerås | SE-723 35 | Sweden |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |