Surgical Resection of Latent Brain Tumors Prior to Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of surgical resection by short and long term outcomes
研究概览
简要总结
This clinical trial evaluates the side effects and possible benefits of operating on brain tumors prior to the tumor coming back (recurrence). Understanding when surgery is most useful to patients with brain tumors is important. Some patients may undergo chemotherapy or radiation but still have visible tumor remaining after treatment. The purpose of this research is to compare outcomes of those who have surgery after chemotherapy or radiation, but prior to tumor recurrence, to those who have surgery at a different time, or no surgery at all.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the safety and feasibility of surgical resection for pre-recurrent brain tumors.
SECONDARY OBJECTIVES:
I. To determine whether there are differences in overall survival for patients who receive radiation therapy (RT) prior to surgery as compared to patients who receive RT after surgery or patients undergoing no further surgery.
II. To determine for patients having pre-recurrent surgery whether there is a longer interval to local/regional progression, any central nervous system (CNS) progression or need for subsequent intracranial treatment compared to patients receiving post-operative RT, time to each will be separately documented.
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
- •Age >= 18 years
- •Histological or cytological confirmation of brain tumor and/or suspected brain tumor based on clinical and radiologic findings
- •Prior chemotherapy and/or radiation treatment directed to the known/suspected tumor
- •Radiographic evidence of residual or previously unresected tumor
- •Willingness to undergo surgery and sign informed consent
- •Patients not currently eligible for an alternate competing interventional clinical trial
- •Enrollment in the Mayo Clinic Cancer Center Neuro-Oncology Program Registry for the study of Nervous System Tumors (IRB#12-003458)
排除标准
- •Age < 18 years
- •Found to be a member of a vulnerable population (e.g. pregnant, lacking capacity to consent) during the course of pre-enrollment or pre-surgical assessment
- •Prior gross total resection of brain tumor leading to absence of visible latent disease (exemption available for post-operative enrollment)
- •Any contraindication to surgery, including anyone who in the opinion of the surgeon is at unreasonably elevated risk of wound complications
- •Patients who have not yet undergone surgery or radiation, but who would be appropriate candidates for an alternate interventional clinical trial (e.g. post-operative fractionated vs single fraction radiation to the surgical cavity for surgical brain metastases)
研究组 & 干预措施
Treatment (surgery)
Patients undergo surgery as indicated clinically when applicable.
干预措施: Brain Surgery (Procedure)
结局指标
主要结局
Feasibility of surgical resection by short and long term outcomes
时间窗: Up to 5 years
Feasibility will be evaluated by meeting enrollment criteria.
Incidence of adverse events
时间窗: Up to 5 years
Safety will be evaluated by recording adverse events utilizing proper reporting measures.
次要结局
- Progression free survival(Time from initial diagnosis to the date progression is identified, assessed up to 5 years)
- Neurosurgical morbidity(Up to completion of surgery)
- Time to subsequent treatment (i.e. chemotherapy/immunotherapy and/or radiation)(Time from surgical resection at Mayo Clinic until an adjuvant treatment is administered, assessed up to 5 years)
- Rate of local recurrence(Up to 5 years)
- Overall survival(Time from initial diagnosis to the date of death/or censored at the time of last known alive, assessed up to 5 years)
- Rate of leptomeningeal disease(Up to 5 years)