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

Launched by THE CHRISTIE NHS FOUNDATION TRUST · May 14, 2024

Keywords

ClinConnect Summary

The PRONTO study is looking at how Proton Beam Therapy (PBT) can help patients with parotid gland cancer after they have had surgery. PBT is a special type of radiation treatment that targets cancer cells more precisely, which may reduce side effects like losing the ability to taste and having a dry mouth—common issues with traditional radiation therapy. The goal of this study is to see if PBT can minimize these side effects while still effectively treating the cancer.

To participate in this study, individuals need to be at least 18 years old and have been diagnosed with cancer of the parotid gland that requires radiation treatment after surgery. Participants will be closely monitored by a medical team and will fill out questionnaires to track their experiences. The study is not yet recruiting, but it will offer support for those who may need to travel to treatment centers in Manchester or London. It's important for potential participants to understand that they will need to commit to follow-up visits and comply with the study's guidelines.

Gender

ALL

Eligibility criteria

• 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