Trials
Search / Trial NCT06421649

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

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

Trial Information

Current as of February 19, 2025

Not yet recruiting

Keywords

Proton Beam Therapy Protons Evaluative Commissioning

ClinConnect Summary

Malignant parotid tumours are uncommon. Whilst 85% of salivary gland tumours originate in the parotid gland, only 20-25% of these are malignant, representing only 3-6% of head and neck cancers. This is about 650 patients/year in the UK.

Standard treatment for local disease is with surgical resection followed by adjuvant radiotherapy for patients with high-risk features. Local control and 5-year survival rates are good, at \>70% and \>80% respectively, but radiotherapy is associated with considerable toxicity. More than 70% of patients receiving photon therapy experience significant dysgeus...

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

Trial Officials

Chris Nutting

Principal Investigator

Royal Marsden NHS Foundation Trust

About The Christie Nhs Foundation Trust

The Christie NHS Foundation Trust is a leading provider of cancer treatment and research in the UK, renowned for its commitment to innovative and high-quality patient care. As a prominent clinical trial sponsor, The Christie focuses on advancing cancer therapies through rigorous research and collaboration with academic institutions and industry partners. The Trust is dedicated to improving treatment outcomes and quality of life for cancer patients by facilitating cutting-edge clinical trials, fostering a culture of excellence in research, and ensuring the highest ethical standards in all its endeavors.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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