Advanced Techniques for Single-fraction Palliative Radiotherapy Versus Standard Single Fraction Radiation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Substantial benefit from palliative radiotherapy
研究概览
简要总结
One third of patients treated in the radiation oncology departments are treated with palliative intent. These patients can be unwell due to their advanced disease and suffering from pain and other symptoms related to metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients.The aim of the study is to determine if escalated single fraction palliative radiotherapy using intensity-modulated techniques results in a prolonged duration of benefit for patients otherwise suitable for standard single fraction radiotherapy.
详细描述
Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for palliative patients who can be unwell due to their advanced disease and who suffer from pain and other symptoms related to metastases.
A single fraction of 8Gy is considered a standard treatment. In an assessment of health related quality of life (HRQoL) after palliative RT for painful bone metastases, the overall radiotherapy response at 1 week was 45% and by week 2 was 62%. Patients had a significant decrease in pain, insomnia and constipation by 1 month post treatment and an improvement in emotional functioning. When RT is used to control a bleeding tumour, up to 90% of patients will experience haemostasis.
There is however concern that 8 Gy in 1 fraction will not provide a durable response, with up to 20% of patients requiring retreatment to the same site, compared with 8% who receive multiple fraction treatment. Single fraction palliative radiation therapy (SFRT) is therefore an under utilised treatment regimen.
To implement the higher doses with a single fraction, more advanced radiation techniques are required, and there is still equipoise regarding the benefits. With advances in linear accelerator design and software, it is now possible to treat patients with advanced radiation techniques and low resources. Standard clinical pathways including computer optimised planning, remote (virtual) QA of plan delivery and the use of diagnostic imaging for planning are all feasible (under currently in clinical use at Northern Sydney Cancer Centre).
The results from this study will be used to design / proceed to a Randomised Phase III study, if appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Treatment arm will be masked to investigators. Participants will not be masked.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic cancer
- •Recommended for 8Gy/1# palliative radiation
- •Patients with spinal cord compression are eligible for enrolment
排除标准
- •Unwilling or unable to give informed consent
- •Patients who are recommended multi fraction palliative radiation
研究组 & 干预措施
Standard Arm
8 Gy / 1 Fraction
干预措施: Radiation Therapy (Radiation)
Single Fraction Dose Escalation
8Gy Planning Target Volume / 12Gy Clinical Target Volume +/- 14Gy Gross Tumour Volume / 1 fraction
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Substantial benefit from palliative radiotherapy
时间窗: 9 months
to determine the percentage of patients who achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment.
次要结局
- Treatment Wait Time(1 week)
- Radiation Department Time(1 day)
- Radiotherapy Treatment Time(1 day)
- Comparing Patient and Carer Assessments(2 years)
- Radiation Doses to Organs at Risk(2 years)
- Patient Reported Outcomes(24 months)
- Carer Reported Outcomes(24 months)
- Completion Rates of ePRO's in a Palliative Care Cohort(2 years)
- Efficacy of treatment(2 years)
- Overall Survival(2 years)
研究者
Professor Thomas Eade
Radiation Oncologist
Royal North Shore Hospital