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

NCT06421649 | Not Yet Recruiting

• 1 other identifier: CFTSp218 (01)
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Parotid Cancer

Keywords

proton beam therapy; protons; evaluative commissioning

Outcome Measures

Primary Outcomes (1)

• Taste dysfunction

  Taste dysfunction as recorded on the European Organisation for the Research \& Treatment of Cancer (EORTC) Head \& Neck 43 (HN43) patient reported questionnaire. 43 questions with a Likert scale of 1 - 4 Higher score may mean a worse outcome

  12 months

Secondary Outcomes (12)

• Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades

  up to 24 months

• Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale

  up to 24 months

• Clinician reported acute and late toxicity - measurement of hearing changes

  up to 24 months

• Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire

  up to 24 months

• Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Head & Neck 43 (HN43) patient reported questionnaire.

  up to 24 months

Study Arms (1)

Proton Beam Therapy

EXPERIMENTAL

All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.

Radiation: Proton Beam Therapy

Interventions

Proton Beam Therapy RADIATION

All patients will be offered radical adjuvant proton beam therapy to a dose of 60-66 Gray (Gy) in 30-33 fractions delivered Monday to Friday over 6-6.5 weeks.

Proton Beam Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead
• Royal Marsden NHS Foundation Trust: collaborator
• University College London Hospitals: collaborator

Related Publications (1)

• Romesser 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 BACKGROUND

MeSH Terms

Conditions

Parotid Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Chris Nutting

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romelie Rieu

CONTACT

0044 1619187172; romelie.rieu@nhs.net

Sally Falk

CONTACT

0044 1619187172; sally.falk@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluative commissioning study. This is a single arm, non-randomised study.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 20, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share