Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
ConditionTonsil Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLund University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be at least 18 years old.
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.
World Health Organisation/Eastern Cooperative Oncology Group (WHO/ECOG) performance status 0-1.
The patient must be able to understand the information about the treatment and give a written informed consent.
Disqualifiers
Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years.
Two or more synchronous primary cancers in the head and neck region at time of diagnosis
Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
Trial design
Design model
Parallel
Treatments tested in this trial
Radiotherapy
RadiationRadiotherapy with either photons or protons.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Radiotherapy delivered with photonsActive comparator 1 intervention
Group B: Radiotherapy delivered with protonsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.2
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.Sponsors and contacts
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Source ClinicalTrials.gov