Proton beam therapy for parotid cancer after surgery

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 non-randomized program assesses the role of proton beam therapy (PBT) for post-operative radiotherapy in malignant parotid tumors. Eligible participants receive IMPT-based treatment at UK centers, with long-term follow-up and toxicity monitoring. The goal is to see if PBT lowers radiation exposure to nearby organs and reduces taste loss and other side effects compared with conventional approaches. All eligible patients in the UK can be referred, and travel and accommodation support are provided if needed. Results will inform how best to use PBT within the NHS evaluative commissioning framework.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥ 18 years old.
2. Histologically confirmed primary malignant tumours of parotid gland.
3. Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction.
4. Treatment delivered with radical intent.
5. All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up.
6. Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment.
7. Written informed consent.

Exclusion Criteria:

1. Previous radiotherapy to the head and neck region;
2. Parotid tumours requiring primary radiation or those with gross residual disease;
3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland;
4. Benign tumours requiring post operative radiotherapy;
5. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;
6. Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy.
7. Patients who are eligible for PBT under routine commissioning

Where it's running

• University College London Hospitals NHS Foundation Trust
  London, United Kingdom Recruiting
• The Christie NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Chris Nutting — Royal Marsden NHS Foundation Trust
• Study coordinator: Romelie Rieu
• Email: romelie.rieu@nhs.net
• Phone: 0044 1619187172

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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.