NCT02278744进行中（未招募）1 期
A Phase I Dose Escalation Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria
研究概览
简要总结
This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery 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
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
- •Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
- •Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L2 to sacrum) which is suitable for radiation therapy
- •Patients must have received prior external beam radiation therapy to the region proposed for SRS re-irradiation at least 6 months prior to planned re-irradiation
- •For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior RT. Sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator.
- •Patients must have demonstrated progression of disease on MRI or CT assessment of the spinal cord/cauda within the previous radiation field
- •o progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.
- •Target lesion size for re-irradiation must be ≤ 2 vertebral bodies
- •KPS ≥ 60%
- •Age ≥ 18 years old
排除标准
- •Patients with a life expectancy of < 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1).
- •Patients with intradural or intramedullary lesions, or lesions with < 2mm distance from tumor to spinal cord
- •Patients with circumferential epidural disease
- •Systemic chemotherapy delivered or planned to be delivered within (+/-) 5 days of SRS re-irradiation
- •Patients receiving bevacizumab within 12 weeks prior to protocol treatment.
- •Unable to undergo either a myelogram or MRI of spinal cord/cauda equina and/or exiting spinal nerves
- •Patients who may not receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by the Dose Limit Guidelines Evaluation of doses previously delivered to spinal cord/cauda equina and other critical structures (bowel, esophagus, kidneys, rectum) will be taken into consideration
- •If repeat irradiation would exceed any normal tissue constraint as noted in Appendix 2, the patient will be ineligible
- •If the total prior radiation dose to the spinal cord/cauda equina and/or sacrum over all prior treatments exceeds 100 Gy BED (biologically effective dose), the patient will be ineligible, where a total of 100 Gy BED is determined by the calculation: BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord/cauda/sacrum late effect and equals 2 [Rades 2005, Nieder 2005, Sahgal 2012]
- •Patients with paraspinal extension of disease with visceral involvement exclusive of patients with cauda equina and sacral disease extension.
- •Abnormal complete blood count. Any of the following:
- •Platelet count < 75,K/mcL
- •Hemoglobin level < 9g/dl
- •WBC < 3.5K/mcL
- •Abnormal coagulation profile: INR > 2.5 and/or PTT > 80
- •o Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded
- •Pregnant or lactating women.
结局指标
主要结局
toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria
时间窗: 1 year
The toxicities associated with single fraction stereotactic radiosurgery to the spine may be classified as either early (occurring within 90 days of the treatment) or late toxicities (after 90 days to 1 year). These toxicities will be evaluated with the National Cancer Institute (NCI) Common Toxicity Criteria.
次要结局
- local failure(1 year)
- overall survival(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
'Re-Priming' RT After Incomplete Response to CAR-T in R/R NHLNon-Hodgkin LymphomaNCT04601831University of Texas Southwestern Medical Center14
进行中（未招募）
不适用
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast CancerAnatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Invasive Breast CarcinomaNon-Metastatic Breast CarcinomaPrognostic Stage 0 Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8NCT04871516Rutgers, The State University of New Jersey103
招募中
1 期
A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)NCT05885412Rocket Pharmaceuticals Inc.9
招募中
1 期
Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck CancerHead and Neck CancerHead and Neck Squamous Cell CarcinomaHead and Neck CarcinomaHead and Neck Cancer Stage IVHead and Neck Cancers - ThroatNCT05526924University of Chicago30
已完成
1 期
Diffuse Intrinsic Pontine Glioma (DIPG) Reirradiation (ReRT)Brain CancerNCT01469247M.D. Anderson Cancer Center12