Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
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 inte
| Condition(s) | Tonsil Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. The patient must be at least 18 years old. 2. Histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the tonsil T1-2 (p16-positive or p16-negative) N0-1 M0 (p16-positive)/N0-N2b M0 (p16-negative) according to AJCC 8th edition, aimed for unimodal and ipsilateral treatment with radiotherapy with curative intent. The treatment may be followed but not preceded by surgery, which would be as a salvage procedure and not part of the planned treatment. An excision of a lymph node, or a tonsillectomy for diagnostic purposes does not exclude the patient from participation. 3. World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1. 4. The patient must be able to understand the information about the treat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Lund University Hospital |
| Locations | Gävle, Sweden; Gothenburg, Sweden; Jönköping, Sweden; Karlstad, Sweden; Linköping, Sweden; Lund, Sweden (+6 more sites) |
| Start date | 2019-01-22 |
| NCT ID | NCT03829033 |
| Official listing | https://clinicaltrials.gov/study/NCT03829033 |