Parotid Cancer Clinical Trial
— PRONTOOfficial title:
An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised 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.
Status | Not yet recruiting |
Enrollment | 97 |
Est. completion date | January 1, 2029 |
Est. primary completion date | January 1, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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The Christie NHS Foundation Trust | Royal Marsden NHS Foundation Trust, University College London Hospitals |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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 | Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades | Using the CTCAE toxicity grade Grades 1 - 5 Higher score may mean a worse outcome | up to 24 months | |
Secondary | Clinician reported acute and late toxicity using Late Effects Normal Tissue - Subjective Objective Management Analytic (LENT-SOMA) scale | Using the LENT-SOMA scale A multiple item scoring system composed of four domains; subjective, objective, management and analytic.
Grades 0-4 Higher score may mean a worse outcome |
up to 24 months | |
Secondary | Clinician reported acute and late toxicity - measurement of hearing changes | Using pure tone audiometry to measure hearing changes Loss of hearing may mean a worse outcome | up to 24 months | |
Secondary | Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 module questionnaire | Using the EORTC QLQ-C30 30 questions using a Likert scale of 1-4 Higher score may mean a worse outcome | up to 24 months | |
Secondary | Patient reported acute and late toxicity using European Organisation for the Research & Treatment of Cancer (EORTC) Head & Neck 43 (HN43) patient reported questionnaire. | Using the EORTC HN43 patient reported questionnaire 43 questions using a Likert scale of 1-4 Higher score may mean a worse outcome | up to 24 months | |
Secondary | Patient reported acute and late toxicity using University of Washington Quality of Life (UW-QoL) questionnaire | Using the UW-QoL questionnaire Most questions are scored on a Likert scale, 0=worst, 100=best Lower score may mean worse outcomes | up to 24 months | |
Secondary | Patient reported acute and late toxicity using Glasgow hearing Aid Benefit Profile (GHABP) questionnaire | Using the GHABP questionnaire Possible values for response options (0=not applicable, 5=cannot manage at all) Higher score may mean worse outcomes | up to 24 months | |
Secondary | Loco-regional tumour control | This will be measured as time to recurrence (measured in months from completion of treatment) and location of recurrence (within the primary nodal regional or distant spread) | up to 24 months | |
Secondary | Overall survival | This will be measured in months from completion of treatment to death | up to 24 months | |
Secondary | Patient participation in the study each year | Number of patients referred to and participating in the study annually | up to 24 months | |
Secondary | Study completion rates | Review the number of patients completing radiotherapy and the number of patients completing follow up on the study as per protocol. | up to 24 months | |
Secondary | Oral cavity radiation dose | Patients will be re-planned with photon radiotherapy, the dose distribution differences between the treatment proton plans and photon plans will be recorded in particular the dose to the oral cavity | 12 months |
Status | Clinical Trial | Phase | |
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Recruiting |
NCT03849482 -
Multiparametric Magnetic Resonance Imaging Versus Fine Needle Aspiration Cytology for Parotid Gland Neoplasms
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