Pencil Beam Scanning Proton Beam Radiotherapy for the Management of Abdominal Neuroblastoma - an Evaluative Commissioning in Protons (ECIP) Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Comparison of decision regarding radiotherapy technique selection at three time points of the patient and radiotherapy pathway
研究概览
简要总结
Proton Beam Therapy (PBT) and Evaluative Commissioning in Protons (ECIP):
PBT is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the United Kingdom, in Manchester and London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT. ECIP is a programme of studies exploring the role of PBT in different types of cancer funded by NHS England. ECIP studies are not randomised, eligible patients will be offered PBT. Any eligible UK patient can be referred, and accommodation is available for patients who don't live close to a PBT centre. The main benefit of PBT, compared with standard photon radiotherapy, is 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.
SUPERMAN:
SUPERMAN is a study within the ECIP programme. It is sometimes not entirely clear whether PBT or photon radiotherapy is better for the treatment of a patient with abdominal neuroblastoma. The aim of SUPERMAN is to choose the best radiotherapy technique and to better understand how to monitor and adapt PBT for these patients.
详细描述
Introduction:
Neuroblastoma is a rare childhood cancer, occurring in about 100 children in the UK each year. Most arise from nerves in the retroperitoneum - this is an area at the back of the abdomen, behind the stomach and bowel. There are many important structures in the retroperitoneum including the kidneys, adrenal glands, and parts of large blood vessels.
The treatment of neuroblastoma can include surgery, chemotherapy and radiotherapy. Radiotherapy is typically delivered after chemotherapy and surgery, depending on the response to previous treatments. Its aim is to improve local control and overall survival. The dose and schedule of radiotherapy is currently being investigated in a randomised Phase III pan-European trial called SIOPEN-HR-NBL2 (European Society for Paediatic Oncology High-Risk Neuroblastoma 2 trial). It is important to note that any patients involved in SUPERMAN will also be able to participate in any other radiotherapy study, including SIOPEN-HR-NBL2.
How advanced radiotherapy techniques can reduce treatment related side effects:
Typically, patients are diagnosed with neuroblastoma at a very young age, usually under 5 years old. There is a risk of late side-effects following radiation treatment, including secondary cancers. The risk of late-effects, and their severity, may be worse if patients already have health problems, such as problems with kidneys. Kidney problems may be due to the cancer itself or prior treatments. Therefore, particularly for patients most at risk, it is critical to reduce radiotherapy related side effects as much as possible.
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
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with histologically confirmed abdominal or abdominal-pelvic neuroblastoma who are eligible and fit for radical radiotherapy.
- •Written informed consent from patient, parent or guardian - this includes consent for the minimum baseline, treatment and follow up assessments; and for their data to be stored and used for research, within the appropriate Proton Clinical Outcomes Units and NHS Proton Registry.
- •Patients registered female at birth of childbearing potential agree to use effective contraception between the planning Computed Tomography (CT) scan and the end of treatment.
排除标准
- •Pregnant patient
结局指标
主要结局
Comparison of decision regarding radiotherapy technique selection at three time points of the patient and radiotherapy pathway
时间窗: From date of first patient enrolment until the date of the last patient treatment (up to 36 months)
Comparison of decision regarding radiotherapy technique selection (PBT vs IMRT) at three time points of the patient and radiotherapy pathway: 1. Selection 1 - Proposed modality at time of referral - Pre-planning 2. Selection 2 - Post planning 3. Selection 3 - Post completion of radiotherapy
次要结局
- Measure and compare dose to target volume of PBT versus IMRT plans.(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Measure and compare dose to organs at risk of PBT versus IMRT plans.(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Measure and compare dose to normal tissues of PBT versus IMRT plans.(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Number of PBT re-plans and reasons (including delays)(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Number of patients requiring PBT to IMRT treatment modality conversions and the reasons for this.(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Evaluation of on-treatment imaging(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Evaluation of on-treatment delivery data(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Comparison of planned versus delivered dose for PBT plans(From date of first patient enrolment until the date of the last patient treatment (up to 36 months))
- Local control at 2 years(2 years from the end of recruitment)
- Event free survival and overall survival at 2 years(2 years from the end of recruitment)
- Acute toxicity and late toxicity(6 weeks after the end of treatment)