Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
研究概览
简要总结
This pilot clinical trial studies the side effects of spectroscopic magnetic resonance imaging (MRI)-guided radiation therapy and how well it works in treating patients with newly-diagnosed glioblastoma or gliosarcoma. Spectroscopic MRI can show doctors where the extent of tumor is in the brain beyond current clinical MRI scans by mapping areas of high tumor metabolism. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Spectroscopic MRI-guided radiation therapy may work better in treating patients with glioblastoma or gliosarcoma.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of using spectroscopic MRI (sMRI) to guide dose-escalated radiation therapy (RT) for newly-diagnosed glioblastoma (GBM)s.
II. To determine the safety of using sMRI to guide dose-escalated RT for newly-diagnosed GBMs.
SECONDARY OBJECTIVE:
I. To determine whether the progression free survival at 1 year with sMRI-guided, dose-escalated RT is improved for newly-diagnosed GBMs.
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
- •Patients must have a newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically by a board-certified neuropathologist
- •Patients must be able to have MRI scans
- •Patients must have the following lab values ≤ 14 days prior to registration:
- •White blood cell (WBC) ≥ 3,000/µL
- •Absolute neutrophil count (ANC) ≥ 1,500/µL
- •Platelet count of ≥ 75,000/µL
- •Hemoglobin ≥ 9.0 gm/dL (transfusion is allowed to reach minimum level)
- •Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0 x upper limit of normal (ULN)
- •Bilirubin ≤ 2 x ULN
- •Creatinine ≤ 1.5 mg/dL
- •Patients must have a life expectancy of ≥ 12 weeks
- •Patients must have a Karnofsky performance status (KPS) ≥ 60
- •Patients who are women of childbearing potential must have a negative pregnancy test documented ≤ 14 days prior to registration; this is not specific to dose escalation and is mandatory for standard care for patients being treated with radiation therapy; the cost of this test will be covered by standard of care
- •Patients must be able to understand and provide written informed consent
- •Members of all races and ethnic groups are eligible for this trial; subjects will be approximately representative of the demographics of the referral base for the participating institutions
- •Patient must be able to swallow capsules
- •Patients must be willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol
排除标准
- •Patients with pacemakers, aneurysm clips, neurostimulators, cochlear implants, metal in ocular structures, history of being a steel worker, or other incompatible implants which makes MRI safety an issue are excluded
- •Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy are excluded
- •Patients with a history of any other invasive cancer (except non-melanoma skin cancer and excluding carcinoma in-situ), unless in complete remission and off of all therapy for that disease for ≥ 3 years, are ineligible
- •Patients with an active infection or serious intercurrent medical illness are ineligible
- •Patients receiving any other investigational agents are excluded
- •Patients who have received prior cytotoxic, non-cytotoxic or experimental drug therapies for brain tumor are excluded
- •Patients with a history of prior cranial radiation are ineligible
- •Patients may not be enrolled on any other therapeutic trial for which they are receiving an anti-tumor therapy
- •Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum
- •The maximum radiation target volume for gross tumor volume 3 (GTV3) is 65 cc (per NRG Oncology guide); patient may be excluded after the first sMRI scan if the GTV3 volume is greater than 65 cc (we anticipate that contrast-enhancing tumor volume [residual tumor volume following tumor resection] would be less than 20 cc)
研究组 & 干预措施
sMRI-Guided RT with TMZ
Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.
干预措施: Dose-Escalated Radiation Therapy (Radiation)
sMRI-Guided RT with TMZ
Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.
干预措施: Spectroscopic Magnetic Resonance Imaging (Procedure)
sMRI-Guided RT with TMZ
Patients undergo spectroscopic magnetic resonance imaging-guided dose-escalated radiation therapy daily for the first 5 days of every week (Monday - Friday) over 6 weeks. Patients also receive standard of care temozolomide PO daily during radiation therapy for up to 42 days.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Feasibility as Assessed by Successful Co-registration of sMRI-based Treatment Volumes With Clinical Images Into the Radiation Treatment Execution Platform
时间窗: Up to 2 years after completion of therapy
Feasibility of this approach will be determined by whether treatment volumes based on sMRI can be co-registered with clinical images and transferred into the radiation treatment execution platform in a seamless manner, so that sMRI information can be efficiently applied to the patient treatment.
Incidence of Adverse Event Assessed by Common Terminology Criteria for Adverse Events Version 4.0
时间窗: Up to 2 years after completion of therapy
The safety of sMRI to guide dose-escalated RT will be confirmed by assessing toxicity potentially attributable to the RT.
次要结局
- Progression Free Survival (PFS)(2 years from the start of RT.)
研究者
Hui-Kuo Shu
Principal Investigator
Emory University