NCT04422639终止不适用
A Phase II Pilot Trial of Preoperative SRS/SRT Versus Postoperative SRS/SRT for Brain Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants With Central Nervous System (CNS) Composite Event (CE)
研究概览
简要总结
This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases.
The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases.
The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.
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
- 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 with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
- •MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
- •Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
- •1-2 index lesion(s) appropriate for resection, not previously treated with SRS/SRT.
- •Index lesion(s) should be > 2 cm and < 5 cm in largest dimension, and require resection. Alternatively, patients with a diagnosis of melanoma and a lesion < 1.5cm in largest dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT alone and treated according to physician preference. Prior neurosurgery and/or prior SRS/SRT at a non-overlapping location are permitted at the discretion of the treating physician.
- •MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.
- •Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.
- •Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (≤ 10 metastases).
- •Surgical resection able to be performed within 15 days of radiotherapy completion.
- •Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
- •Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
- •Platelet count > 80 k/cumm, Hgb > 7.5 gm/dL, INR < 1.3, ANC > 1.5 k/cumm
排除标准
- •Not a surgical candidate per neurosurgeon's discretion.
- •Contraindication to general anesthesia.
- •Not a radiosurgical candidate per radiation oncologist's discretion.
- •Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
- •ECOG > 2
- •< 3 months expected survival
- •Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus
- •Radiographic or cytologic evidence of leptomeningeal disease.
- •Imaging Findings:
- •Midline shift > 6mm
- •>10 lesions, one of which is the index lesion
- •Largest lesion > 5cm
- •Pregnancy
- •Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible.
- •Patients who have local recurrence of previously treated brain metastasis.
- •Patients who have received prior WBRT.
- •Inherited radiation hypersensitivity syndromes
- •o Ataxia Telangiectasia, Nijmegen Breakage Syndrome, Fanconi Anemia, DNA Ligase IV, Mre 11 deficiency, SCID, Bloom's syndrome
- •Collagen vascular diseases
- •o Active systemic lupus erythematous (SLE), scleroderma, mixed connective tissue disorder, polymyositis or dermatomyositis, CREST Syndrome
- •Cytotoxic Chemotherapy within 7 days prior to SRS/SRT.
- •o Molecularly targeted therapies, including immune-modulatory drugs, can be given within 7 days of SRS/SRT at the discretion of the treating physician.
- •Patients who received anti-VEGF therapy within 6 weeks prior to enrollment, as there is increased risk of fatal brain hemorrhage with surgical resection.
- •Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved.
结局指标
主要结局
Number of Participants With Central Nervous System (CNS) Composite Event (CE)
时间窗: From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.
A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).
次要结局
未报告次要终点
研究者
研究点 (2)
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