Phase IIR Trial of Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Intact Metastatic Brain Disease (FRACTIONATE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
研究概览
简要总结
This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.
详细描述
PRIMARY OBJECTIVE:
I. To ascertain if the composite endpoint of cumulative treatment failure, defined by time to either local failure or symptomatic radiation brain necrosis of the largest brain metastasis (target lesion), is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).
SECONDARY OBJECTIVES:
I. To ascertain whether there is improved overall survival in patients who undergo FSRS compared to patients who receive SSRS.
II. To tabulate and descriptively compare the post-treatment adverse events associated with the interventions, including the potential impact of immunotherapy and targeted therapy.
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
- •Age >= 18 years old
- •Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)
- •Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible
- •Size of brain metastases
- •At least one intact metastasis (not previously treated with radiosurgery) must measure >= 2.0 cm and =< 4.0 cm in maximal extent on the contrasted pre-treatment magnetic resonance imaging (MRI) brain scan obtained =< 28 days prior to registration
- •If the largest lesion measures >= 2.0 to =< 4.0 cm in maximal extent the patient will be randomized
- •Able to undergo contrast enhanced MRI brain
- •Negative urine or serum pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only
- •Patient is willing and able to provide written informed consent or have a legally Authorized Representative (LAR) who is responsible for the care and well-being of the potential study participant provide consent.
- •Karnofsky performance status (KPS) >= 50
- •Eastern Cooperative Oncology Group (ECOG) performance score of (PS) >= 2
- •Past radiosurgery or resection is allowed as long as no definitive evidence of progression in these locations
- •Note: Repeat radiosurgery to the same location/lesion is not allowed on this protocol
排除标准
- •Any patient who has received previous whole brain radiation
- •Any brain metastasis that is located in the brainstem measuring >= 2.0 cm in maximal extent
- •Any patient with definitive evidence of leptomeningeal metastasis (LMD)
- •NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion
- •Any patient with an intact brain metastasis measuring > 4.0 cm
研究组 & 干预措施
Arm A (single fraction SRS)
Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
干预措施: Questionnaire Administration (Other)
Arm A (single fraction SRS)
Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm A (single fraction SRS)
Patients undergo single fraction SRS. Patients also undergo MRI at screening and during follow up.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm B (fractionated SRS)
Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.
干预措施: Questionnaire Administration (Other)
Arm B (fractionated SRS)
Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.
干预措施: Stereotactic Radiosurgery (Radiation)
Arm B (fractionated SRS)
Patients undergo fractionated SRS, for 3-5 treatments, given over no more than 8 days.. Patients also undergo MRI at screening and during follow up.
干预措施: Magnetic Resonance Imaging (Procedure)
结局指标
主要结局
Time to local failure or symptomatic radiation brain necrosis of large brain metastasis
时间窗: Up to 5 years
Will determine if the composite endpoint of time to local failure or symptomatic radiation brain necrosis of a large brain metastasis \[cumulative treatment failure (CTF)\] is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).
次要结局
- Per lesion analysis between treatment arms: time to local failure(Up to 5 years)
- Per lesion analysis between treatment arms: time to necrosis(Up to 5 years)
- Per lesion analysis between treatment arms: endpoint CTF(Up to 5 years)
- Overall survival (OS)(From study entry to death from any cause, assessed up to 5 years)
- Incidence of adverse events(Up to 2 years post radiation therapy)
- Central nervous system (CNS) failure patterns (Fractionation)(Up to 5 years)
- Time to neurologic death(Up to 5 years)
- Quality of life (QOL)(Up to 5 years)
- CNS failure patterns (Gamma Knife)(Up to 5 years)
- Rates of radiation necrosis(Up to 5 years)