A Phase 2 Study of Short Interval Postoperative Stereotactic Body Radiation Therapy (SBRT) After Surgical Intervention for Spine Metastases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Local Control (LC) Rate
研究概览
简要总结
Current guidelines suggest postoperative spine Stereotactic Body Radiation Therapy (SBRT) should be delivered within 2-4 weeks after surgery. This approach is rife with logistical complications that create delays and barriers for patients accessing care. An alternative approach delivers postoperative spine SBRT soon after surgery, starting within a single hospital stay. This study will investigate the effects of short-term postoperative spine SBRT on wound complications in a safety lead-in, then will transition to a phase 2 trial investigating local tumor control.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the local control rate (LC) of treated metastatic sites in patients who undergo surgery for spinal metastasis followed by short interval postoperative spine Stereotactic Body Radiation Therapy (SBRT).
SECONDARY OBJECTIVE:
I. Evaluate the postoperative wound complication rate in participants who undergo surgery for spinal metastasis followed by short-interval postoperative spine SBRT.
II. Determine the radiation toxicity of short-interval postoperative spine SBRT in participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Participants must have a histologically or cytologically confirmed diagnosis of metastatic malignancy or must have preliminary histology or cytology consistent with a diagnosis of metastatic malignancy.
- •Participants must be considered candidates for postoperative SBRT by the treating radiation oncologist.
- •Participants must have undergone, within the past 13 days, or are planned to undergo minimally invasive or open surgery for the management of a spine metastasis.
- •Disease at any spine level is allowed.
- •Prior therapy
- •There is no limit on the number of prior spine surgeries or prior courses of radiotherapy directed at the spine if prior therapies occurred at different spinal levels outside the anticipated treatment field.
- •There is no limit on the number of courses or types of radiotherapy for radiation delivered outside the planned treatment field.
- •Cleared by the primary surgical team for postoperative SBRT, including but not limited to hemodynamic, respiratory, and neurologic stability postoperatively, without immediate postoperative complications noted.
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%, see Appendix 1) 1 month prior to presentation for surgery.
- •Estimated survival >3 months or survival considered adequate to undergo spine surgery as assessed by the primary surgical team.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Ability to understand and willingness to comply with treatment schedule, follow-up visits, laboratory testing, and other requirements of the study, including disease assessment by MRI.
- •Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •The effects of radiation on the developing human fetus are generally considered detrimental. Because the radiation therapy used in this trial is known to be teratogenic, individuals of reproductive potential must agree to use adequate contraception (e.g., hormonal or barrier methods, abstinence) for the duration of study participation and for at least 120 days after the last administration of radiation therapy. Should a study participant or their partner become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Prior radiation of any type within the anticipated treatment field (prior radiation outside the anticipated field is acceptable as above).
- •Primary malignancy of the spine (examples: chordoma or sarcoma).
- •Persistent high-grade metastatic spinal cord compression following surgery (Bilsky Grade 3 or higher).
- •Involvement of 3 or more contiguous spinal levels.
- •Involvement of more than 2 non-contiguous spinal levels.
- •American Spinal Injury Association Impairment Scale (ASIA) Grade 3 status.
- •Surgery was a biopsy only.
- •Unable to undergo MRI for any reason.
- •Estimated survival <3 months.
- •Active infection requiring systemic therapy.
- •Active wound complication requiring medical intervention.
- •History of radiation-induced myelopathy from prior spine radiation.
- •History of a collagen vascular disorder (examples: lupus, scleroderma).
- •History of psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •. A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
研究组 & 干预措施
Treatment - Decompression Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Computed Tomography (CT) Simulation (Procedure)
Treatment - Decompression Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Questionnaires (Behavioral)
Treatment - Debulking Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Treatment - Debulking Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Computed Tomography (CT) Simulation (Procedure)
Treatment - Debulking Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Questionnaires (Behavioral)
Treatment - Decompression Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Treatment - Decompression Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal decompression surgery will receive Stereotactic Body Radiation Therapy (SBRT) after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
Treatment - Debulking Surgery
Participants diagnosed with metastatic spinal cancer who have undergone spinal debulking surgery will receive SBRT after their operation. The radiation dose, ranging from 16 to 40 Gy, will be determined by the radiation oncologist in accordance with expert guidelines. Precise targeting of the treatment area and identification of nearby organs will be achieved using CT and MRI imaging. SBRT will be administered in one to five sessions (1-5 fractions) in either an inpatient setting or a combination of inpatient and outpatient settings. Participants are followed for 1 year after their last treatment. Participants removed from the study for unacceptable treatment or study-related adverse event(s) are followed until resolution or stabilization of all treatment-related adverse events to grade 2 or lower.
干预措施: Magnetic Resonance Imaging (MRI) (Procedure)
结局指标
主要结局
Local Control (LC) Rate
时间窗: 6 months after SBRT
Local control (LC) is defined as the time from SBRT radiotherapy to metastatic lesions (event) within the SBRT treatment field with stable or decreased size as measured by a board-certified radiologist on follow-up imaging. Participants without any documented events or death will be censored. Estimates and confidence interval will be reported using the Kaplan Meier method.
次要结局
- Median Wound Complication Rate(1 month after surgery)
- Proportion of Participants with Treatment-emergent Adverse Events (TrAE)(1 month after SBRT)
- Median Progression-Free Survival (PFS)(Up to 6 months after SBRT)
- Median Progression-Free Survival (PFS)(Up to 12 months after SBRT)
- Median Overall Survival (OS)(Up to 6 months after SBRT)
- Median Overall Survival (OS)(Up to 12 months after SBRT)
- Median Score on the Functional Assessment of Cancer therapy, General- 7 (FACT-G7) at 1 month(1 month)
- Median score on the FACT-G7 at 6 months(6 months)
- Median score on the FACT-G7 at 12 months(12 months)