Comparing Photon and Proton Therapy for Early Tonsil Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial involves patients with early-stage squamous cell carcinoma of the tonsil who will be randomized to receive either photon or proton radiotherapy as a treatment option. The study focuses on patients with specific clinical stages of tonsil cancer, aiming for a curative approach with unimodal and ipsilateral treatment. Participants will be monitored for treatment outcomes to determine the effectiveness of each radiotherapy method.

Why it matters

Who can join: the full rules

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 treatment and give a written informed consent.

Exclusion Criteria:

1. Patients judged to benefit from bilateral radiotherapy or concomitant chemotherapy
2. 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.
3. Two or more synchronous primary cancers in the head and neck region at time of diagnosis
4. Previous surgery or radiotherapy in the head and neck region that may affect the study result, as judged by the investigator
5. Co-existing disease prejudicing survival (expected survival should be \>2 years).
6. Psychiatric or addictive disorders or other medical conditions which in the view of the investigator might impair patient compliance
7. 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.

Where it's running

• Gävle Hospital
  Gävle, Sweden Recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Jönköping Hospital
  Jönköping, Sweden Recruiting
• Karlstad Hospital
  Karlstad, Sweden Recruiting
• Linköping University Hospital
  Linköping, Sweden Recruiting
• Lund University Hospital
  Lund, Sweden Recruiting

Study contacts

• Principal investigator: Maria Gebre-Medhin, MD — Lund University Hospiyal
• Study coordinator: Maria Gebre-Medhin, MD
• Email: maria.gebre-medhin@skane.se
• Phone: +46 46 17 75 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.