Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS (FSRS) for Resected Metastatic Brain Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 242
- 试验地点
- 233
- 主要终点
- Surgical bed recurrence-free survival (SB-RFS)
研究概览
简要总结
This phase III trial studies how well single fraction stereotactic radiosurgery works compared with fractionated stereotactic radiosurgery in treating patients with cancer that has spread to the brain from other parts of the body (brain metastases) and has been removed by surgery (resected). Single fraction stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Fractionated stereotactic radiosurgery delivers multiple, smaller doses of radiation therapy over time. This study may help doctors find out if fractionated stereotactic radiosurgery is better or worse than the usual approach with single fraction stereotactic radiosurgery.
详细描述
PRIMARY OBJECTIVES:
I. To ascertain if time to surgical bed failure is increased with fractionated stereotactic radiosurgery (FSRS) compared to single-fraction stereotactic radiosurgery (SSRS) in patients with resected brain metastasis.
SECONDARY OBJECTIVES:
I. To ascertain if there is better emotional well-being at 9 months as assessed by the Functional Assessment of Cancer Therapy-Brain (FACT-BR) in patients with resected brain metastasis undergoing FSRS compared to SSRS (Primary quality of life [QOL] objective).
II. To ascertain whether there is improved overall survival in patients with resected brain metastases who undergo FSRS compared to patients who receive SSRS.
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
- •PRE-REGISTRATION:
- •Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
- •Three or fewer (i.e. 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening.
- •o Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible.
- •Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept.
- •o Note: The metastases size restriction does not apply to the resected brain metastasis.
- •One brain metastasis must be completely (gross total resection) resected =< 30 days prior to pre-registration.
- •o NOTE: May not have had resection of more than one brain metastasis.
- •The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI.
- •Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained =< 30 days prior to pre-registration.
- •Karnofsky performance status of >=
- •For women of childbearing potential only, a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required.
- •Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment.
- •A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to complete an MRI of the head with contrast.
- •The brain metastasis must be located > 5 mm of the optic chiasm; the brain metastasis must be located outside the brainstem (i.e. not inside the brainstem).
- •Must not have any prior whole brain radiation therapy.
- •Past radiosurgery to other lesions is allowed.
- •o NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e. repeat radiosurgery to the same location/lesion is not allowed on this protocol).
- •May not have primary germ cell tumor, small cell carcinoma, or lymphoma.
- •No evidence of leptomeningeal metastasis (LMD).
- •o NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal 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.
- •Must be fluent in English, Spanish, or French.
- •REGISTRATION:
- •Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).
排除标准
- 未提供
研究组 & 干预措施
Arm I (SSRS)
Patients undergo SSRS over 1 session.
干预措施: Quality-of-Life Assessment (Procedure)
Arm I (SSRS)
Patients undergo SSRS over 1 session.
干预措施: Questionnaire Administration (Other)
Arm I (SSRS)
Patients undergo SSRS over 1 session.
干预措施: Single Fraction Stereotactic Radiosurgery (Radiation)
Arm II (FSRS)
Patients undergo FSRS over 3 or 5 daily sessions.
干预措施: Fractionated Stereotactic Radiosurgery (Radiation)
Arm II (FSRS)
Patients undergo FSRS over 3 or 5 daily sessions.
干预措施: Quality-of-Life Assessment (Procedure)
Arm II (FSRS)
Patients undergo FSRS over 3 or 5 daily sessions.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Surgical bed recurrence-free survival (SB-RFS)
时间窗: From the time of randomization up to 2 years post radiation
Surgical bed control is defined as the absence of new nodular contrast enhancement in the surgical bed. In other words, a surgical bed recurrence-free survival (SB-RFS) event is defined as radiographic evidence of a new contrast-enhancing lesion (specifically any new progressive enhancing nodularity) at the site of the surgical resection. Will use a stratified log-rank test that compares and will report the median SB-RFS times between the single fraction stereotactic radiosurgery (SSRS) and fractionated stereotactic radiosurgery (FSRS) arms while adjusting for the stratification factors.
次要结局
- Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score for long-term survivors(At 12 months)
- Karnofsky Performance Status (KPS)(Up to 24 months)
- Time until whole-brain radiotherapy (WBRT) due to any reason (e.g. surgical bed recurrence, recurrence/progression at another central nervous system [CNS] site)(Up to 24 months)
- Change in Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score(At 9 months)
- Functional Assessment of Cancer Therapy-Brain (FACT-BR) Emotional sub-scale score for long-term survivors(At 12 months)
- Barthel Activities of Daily Living (ADL) Index(Up to 24 months)
- Functional Assessment of Cancer Therapy-Brain (FACT-BR) total score(At 9 months)
- Linear Analog Self-Assessment (LASA) overall quality of life(At 9 months)
- Incidence of adverse events(Up to 24 months)
- Linear Analog Self-Assessment (LASA) overall quality of life for long-term survivors(At 12 months)
- Karnofsky Performance Status (KPS) for long-term survivors(Up to 24 months)
- Barthel Activities of Daily Living (ADL) Index for long-term survivors(Up to 24 months)
- Overall survival(Up to 5 years)
- Proportion of patients with radiation necrosis(At 24 months)