A Single Center Prospective Phase II Study: Stereotactic Radiosurgery to the Resection Cavity Following Surgical Removal of Brain Metastasis
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Improved local tumor control after resection
研究概览
简要总结
Brain metastases (BM) are the most common intracranial tumors in adults and source of the most common neurological complications of systemic cancer. Surgery and radiation therapy are the most important components in the management of BM with the goal to prolong survival and improve the quality of life. Whole brain radiotherapy (WBRT) has shown to increase local and distant control both with and without surgical resection. However, patients who develop a new or recurrent BM after WBRT and undergo resection are left without adjuvant therapy options. Local recurrence particular in patients with single metastasis does effect both survival and quality of life. In individual cases the option of additional radiotherapy has been suggested and applied. We seek to evaluate the addition of a stereotactic radiosurgery (SRS) boost to the resection cavity both as adjuvant and salvage procedure among patients, who undergo resection of a BM and previously received WBRT or decline WBRT. Goal is to show superior local brain control.
详细描述
Study Purpose
Treatment strategies for recurrent brain metastasis
Limited clinical data support interventions for recurrent BM such as WBRT, re-operation or SRS, depending on previous treatments (6, 45, 48). Two retrospective analyses looked at a total of 130 non-small cell lung cancer (NSCLC) patients with recurrent BM after resection (6, 45). ,Recurrence happened at the original site in approximately two/thirds of the patients and at other sites for the remainders; Re-resection had a significant effect on prolonged survival compared to patients who did not undergo it (p=0.001). A small subgroup of these patients underwent a third resection with a median survival of 42 months. A more recent study looked at resection of BM that had previously been treated with SRS (48). Sixty-one patients with 1-3 previously treated BM recurred and underwent resection. Major neurological morbidity occurred in 2% and no mortality was observed. A multivariate analysis showed that higher RPA class, focal treatment (surgery or SRS), and treatment of new additional lesions significantly affected survival. Re-operation of a previously focally treated BM provided long-term control and positive impact on survival. Additionally, confirming the pathological diagnosis in a recurrent lesion after SRS is important, as radiation necrosis can occur in 2.3%-8.6% of the patients, a condition that requires a different treatment approach than that for recurrent metastasis (5, 10, 14).
Surgery and radiation therapy are important components in the complex treatment of BM and can prolong survival and improve the quality of life. Patients, who develop brain metastasis after WBRT remain with limited options. A resection will diminish the local disease significantly; however adjuvant radiation might further increase the control rate. We plan to evaluate the addition of a stereotactic radiosurgery (SRS) boost to the resection cavity both as adjuvant and salvage procedure in patient, who underwent resection of a BM and previously received WBRT or decline WBRT.
Study Design
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
- •Patient must have undergone surgical resection of a brain metastasis
- •Patients with no more than 3 brain metastases on contrast MRI.
- •Previous WBRT for brain malignancy, except patients with melanoma, renal cell carcinoma.
- •Adult patient aged >
- •Patient must be in adequate general health, as indicated by:
- •Karnofsky performance status equal or greater than
- •The absence of a concomitant life-threatening disease other than the malignancy.
- •Patient must understand the investigational nature of this study and sign informed consent form, approved by the Institutional Review Board.
排除标准
- •Pregnancy
- •Patients unable or unwilling to follow protocol requirements
结局指标
主要结局
Improved local tumor control after resection
时间窗: 6months and 12 months
次要结局
- Overall survival Quality of life(QoL 3-6-12months and overall survival)