An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 97
- 主要终点
- Taste dysfunction
研究概览
简要总结
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.
详细描述
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 dysgeusia (taste loss/alteration). This can be permanent, is associated with weight loss, diminished appetite, dry mouth, and negatively impact on Quality of Life (QoL).
The putative benefit of proton beam radiotherapy (PBT) relates to its characteristic deposition in the body, which limits the radiation dose received by surrounding healthy tissues. We hypothesise that irradiating the post-operative parotid bed with PBT rather than Intensity Modulated Radiation Therapy (IMRT), will reduce the dose delivered to the Organs at Risk (OAR), in particular the oral cavity (OC), leading to a reduction in acute and long term taste loss/alteration. The advantageous physical properties of PBT may also improve other side effects including fatigue, mucositis, nausea & vomiting and potentially hearing problems, as well as overall QoL.
Radiotherapy planning studies:
Radiation planning studies have repeatedly shown statistically significant reductions in the dose delivered to healthy tissues including: the oral cavity, brainstem, spinal cord, contralateral parotid, ipsilateral and contralateral submandibular glands and ipsilateral temporal lobe. In particular, radiotherapy doses to the oral cavity are significantly reduced, typically to below 10 Gray (Gy). No routinely contoured OAR or region of interest was consistently found to have higher doses planning with protons, although skin dose may be higher.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •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
结局指标
主要结局
Taste dysfunction
时间窗: 12 months
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
次要结局
- Clinician reported acute and late toxicity - measurement of hearing changes(up to 24 months)
- Clinician reported acute and late toxicity using Common Terminology Criteria for Adverse Events (CTCAE) grades(up to 24 months)
- Overall survival(up to 24 months)
- Study completion rates(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)
- 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)
- Patient reported acute and late toxicity using University of Washington Quality of Life (UW-QoL) questionnaire(up to 24 months)
- Patient participation in the study each year(up to 24 months)
- Oral cavity radiation dose(12 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)
- Loco-regional tumour control(up to 24 months)
- Patient reported acute and late toxicity using Glasgow hearing Aid Benefit Profile (GHABP) questionnaire(up to 24 months)