A Prospective Study of High Dose Radiotherapy for Palliation: Hi-D
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Local Control
研究概览
简要总结
Palliative radiation is effective for controlling or preventing symptoms such as pain, bleeding, dyspnea, and cord compression. Recently, studies have shown that additional dose escalation may result in superior local control. The investigators propose a phase II single arm trial to evaluate a novel high-dose radiation regimen, which will be 27 Gray in 3 fractions with dose escalation within the tumour (Hi-D).
详细描述
This study is being done to see if a new palliative radiotherapy technique can prevent growth or shrink tumors that are bigger than 5cm, for a longer period of time than traditional palliative radiotherapy. The main outcome the investigators are measuring is called "local control"- this refers to how long the treatment is able to stop a cancer from growing. With traditional palliative radiotherapy, radiation is given in smaller doses over multiple, (usually 5 or 10) treatments (called fractions), and the radiation is spread evenly around the tumor. Radiation dose is measured in Gray (Gy). Generally, standard of care/traditional palliative radiotherapy is given as 20 Gy in 5 fractions or 30 Gy in 10 fractions. The new palliative radiotherapy technique the investigators are testing gives a similar radiation dose overall of 27 Gy but gives much higher doses per fraction in only 3 fractions and uses cutting edge technology to concentrate most of the radiation to the center of the tumor. This means that compared to traditional palliative radiotherapy, there is a higher amount of radiation dose that the participant's body and the particularly the center of the tumor is receiving over a shorter period of time. This means a more aggressive treatment for the participants cancer but can also cause an increased risk for side effects. However, because the investigators will concentrate the high doses of radiation only in the center of the tumor, nearby organs do not get too close to the high doses and are spared. The investigators expect that this technique will be as safe as traditional palliative radiotherapy and have a longer duration of effectiveness (longer local control) compared to the older techniques.
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 (Participant)
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
- •Inclusion Criteria
- •Subjects must meet all of the following criteria to be eligible for participation in this study:
- •Age 18 or older.
- •Able to provide informed consent
- •Patient has histologically confirmed solid tumour malignancy
- •ECOG performance status 0 - 2
- •Life Expectancy > 6 months
- •Locally advanced or metastatic disease with 1-3 target lesions larger than 5cm in minimum dimension, with no more than 2 target lesions in a single organ; patients can have any number of non-target lesions
- •A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment
- •Not suitable for or declined curative-intent treatment
- •Subject has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment
- •MRI spine for patients receiving RT to vertebral or paraspinal metastases
- •Patient is judged able to:
- •Maintain a stable position during therapy
- •Tolerate immobilization device(s) that may be required to deliver radiation safely
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •Hematologic malignancy
- •Disease limited to intracranial sites
- •Serious medical co-morbidities precluding radiotherapy
- •Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
- •Pregnant people
研究组 & 干预措施
High-Dose RT
27Gy in 3 fractions with boost
干预措施: Palliative Radiotherapy (Radiation)
结局指标
主要结局
Local Control
时间窗: 4 years, with 2 years of accrual and 2 years of follow up
to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy
Feasibility of accrual
时间窗: From open to accrual to close to accrual (24 months)
≥20 participants enrolled within 24 months from first patient accrued
Feasibility of blinding
时间窗: From enrollment to RT completion.
Trial Assignment Questionnaire administered post-treatment.
次要结局
- Overall Survival(4 years, with 2 years of accrual and 2 years of follow up.)
- Progression-Free Survival(4 years, with 2 years of accrual and 2 years of follow up)
- Side Effects(4 years, with 2 years of accrual and 2 years of follow up.)
- Local treatment-free survival(4 years, with 2 years of accrual and 2 years of follow up)
- systemic intensification-free survival(4 years, with 2 years of accrual and 2 years of follow up)
- Patient reported Quality of Life(4 years, with 2 years of accrual and 2 years of follow up.)
- Compare changes in local control(From enrollment to end of study, accessed at 6 weeks, and month 3,12,18,24)
- Compare changes in OS(From enrollment to end of study at 24 months or death)