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临床试验/NCT04649125
NCT04649125招募中不适用

Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation

Royal North Shore Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
benefit from palliative radiotherapy

研究概览

简要总结

The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment

详细描述

One third of patients treated in the radiation oncology department are treated with palliative intent. These patients are usually unwell due to their advanced disease and suffering from pain and other symptoms related to bony and soft tissue metastases. Radiation therapy (RT) has an important role in the symptomatic relief and improvement in the quality of life (QoL) for these patients. A meta-analysis of 29 randomised controlled trials (RCTs) estimated the overall response rate (ORR) following RT for bone metastases at approximately 60% with up to one quarter of patients experiencing a complete response (CR). However, palliative patients form a diverse group of patients and selecting the optimal number of palliative treatments which provides an enduring benefit while not being burdensome for the patient can be challenging. The ideal treatment is one that provides lasting symptom control and involves the least number of treatments. Up to one quarter of patients with advanced cancer who undergo palliative RT will die within 1 month of the treatment, while up to 50% of palliative patients will be alive at 12 months . In patients who receive a single fraction of 8Gy, up to 20% of these patients require retreatment to the same site, compared with 8% who receive multiple fraction treatment . One potential option to increase the duration of local control is with hypofractionated, dose escalated radiation.A phase II non-inferiority study investigated this hypothesis in non-spine bone metastases, comparing a single treatment of 12Gy to 30Gy in 10 fractions. The cohort reported a higher pain response in the single fraction dose escalated arm as early as 2 weeks post treatment (62 vs 32%), which was maintained at 9 months (77% vs 46% respectively).

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

Investigators do not know which arm patients have been randomised to

入排标准

性别
All
接受健康志愿者

入选标准

  • Metastatic cancer
  • Recommended for 5-10 fractions 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 for single fraction palliative radiation

研究组 & 干预措施

standard

Active Comparator

standard radiotherapy 5 fractions

干预措施: dose escalation (Radiation)

single fraction dose escalation

Experimental

8Gy to Planned Target Volume, 12Gy to Clinical Target Volume +/- 14Gy to Gross Target Volume

干预措施: dose escalation (Radiation)

结局指标

主要结局

benefit from palliative radiotherapy

时间窗: 9 months

to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 9 months post treatment

次要结局

  • Feasibility of the trial(2 years)
  • Efficacy of treatment(2 years)
  • Trial Safety(2 years)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Professor Thomas Eade

Radiation Oncologist

Royal North Shore Hospital

研究点 (1)

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