Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma

Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment. Evaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available. The main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects. PRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy. Participants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy.

Sex

All

Minimum age

18 Years

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

• BACKGROUNDRomesser PB, Cahlon O, Scher E, Zhou Y, Berry SL, Rybkin A, Sine KM, Tang S, Sherman EJ, Wong R, Lee NY. Proton beam radiation therapy results in significantly reduced toxicity compared with intensity-modulated radiation therapy for head and neck tumors that require ipsilateral radiation. Radiother Oncol. 2016 Feb;118(2):286-92. doi: 10.1016/j.radonc.2015.12.008. Epub 2016 Feb 8. PMID 26867969