Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
研究概览
简要总结
The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
详细描述
Study Groups:
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
- If participant is in Group 1, they will receive spine radiosurgery in a single large dose.
- If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses, which is standard.
Length of Study Participation:
Participant may continue taking part in the study as the doctor thinks it is in their best interest. Participant will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
- •Age >/=18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status /=60%)
- •Life expectancy of greater than 6 months
- •All patients must be able to lie supine
- •All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
- •All patients must have radiographic evidence of progression at a spinal site previously irradiated greater than 6 months prior to randomization. This includes indirect radiation exposure to spinal site.
- •All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy cumulative over multiple session. EQD2/2 is calculated as follows: EQD2/2= biologically effective dose (BED)/(1+d/alpha beta)) where BED=nd(1+d/(alpha beta)) and n=number of fractions, d=dose per fraction and alpha beta ratio of
- •All patients must have a vertebral body site to be treated located from T1 to L5
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- •All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent is the one approved by MD Anderson IRB.
- •Patients undergoing prior surgery or laser interstitial thermotherapy are allowed
- •Both men and women of all races and ethnic groups are eligible for this trial.
排除标准
- •Patients unable to undergo magnetic resonance imaging (MRI) of the spine
- •Prior radiation at the site of interest within 6 months
- •Prior history of radiation at the site of interest resulting in a critical neural tissue dose of EQD2/2 of >42 Gy in a single session
- •Patients unable to lie flat comfortably for 2 hours
- •Pregnancy status will be obtained at time of consent as is routine for all radiation patients. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects
- •Patients with a histology of lymphoma and myeloma histologies
研究组 & 干预措施
Spine Radiosurgery - 3 Doses
Participants receive spine radiosurgery over 3 smaller doses.
干预措施: Spine Radiosurgery (Radiation)
Spine Radiosurgery - 3 Doses
Participants receive spine radiosurgery over 3 smaller doses.
干预措施: Questionnaires (Behavioral)
Spine Radiosurgery - 1 Dose
Participants receive spine radiosurgery in a single large dose.
干预措施: Spine Radiosurgery (Radiation)
Spine Radiosurgery - 1 Dose
Participants receive spine radiosurgery in a single large dose.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
时间窗: 12 months
Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.
次要结局
- Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases(2 years)