Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy.
- Who it may be relevant to
- Registry conditions: Tonsil Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Radiation Radiotherapy
Radiotherapy with either photons or protons.
Primary outcome measures
- Acute side effects. [Time frame: From the third week of radiotherapy, and then weekly during radiotherapy, which ends after 7 weeks.]
- Late side effects. [Time frame: At 2-3 months after completed radiotherapy, then every 3 month for 2 years, and then every 6 month until 5 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Co-existing disease prejudicing survival (expected survival should be >2 years).
- Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
- When dental fillings with amalgam or metal are present close to the tumour area it must be considered if this may affect radiotherapy before inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 12 centers
- Gävle Hospital — Gävle
- Sahlgrenska University Hospital — Gothenburg
- Jönköping Hospital — Jönköping
- Karlstad Hospital — Karlstad
- Linköping University Hospital — Linköping
- Lund University Hospital — Lund
- Örebro University Hospital — Örebro
- Karolinska University Hospital — Stockholm
- … and 4 more centers
Identifiers
NCT: NCT03829033 · Version 2 2018-10-10