Preoperative Radiosurgery in High Grade Glioma: A Phase I Clinical Trial: The NeoGlioma Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event
研究概览
简要总结
This phase I trial finds out the possible benefits and/or side effects of radiosurgery before surgery (preoperative) in treating patients with high grade glioma. Radiosurgery uses special equipment to position the patient and precisely give a single large dose of radiation to the tumor. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving pre-operative radiosurgery may improve the odds of brain tumor control and reduce treatment-related side effects.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility, safety and maximum tolerated dose (MTD) of preoperative radiosurgery in the treatment of patients with biopsy-proven high-grade glioma prior to conventional therapy.
SECONDARY OBJECTIVES:
I. Acute clinical toxicity profile using Common Terminology Criteria for Adverse Events (CTCAE) version 5 (defined as within 4 weeks of completion of postoperative radiotherapy.
II. Radiographic tumor control at 12 months following surgery (per Response Assessment in Neuro-Oncology [RANO] criteria).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Clear clinical and radiographic evidence of primary high grade glioma (HGG) as judged by the Mayo multidisciplinary neuro-oncology team (World Health Organization [WHO] grade III-IV, including glioblastoma) regardless of IDH and MGMT status
- •Patients who underwent a previous biopsy confirming high grade glioma are eligible for enrollment
- •Planned neurosurgical resection of tumor
- •Judged to not be at risk of significant clinical risk (i.e. herniation) with radiation-induced edema prior to resection
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- •Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only. Patients over 50 years of age who decline pregnancy testing are still eligible without a pregnancy test.
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Provide written informed consent
- •Willing to receive adjuvant radiotherapy at enrolling institution at the time of registration
- •Willing to provide tissue and/or blood samples for correlative research purposes
排除标准
- •Any of the following:
- •Pregnant women
- •Nursing women who are unwilling to cease during therapy
- •Men or women of childbearing potential who are unwilling to employ adequate contraception
- •Prior history of cranial radiotherapy
- •Unwillingness to participate in study
- •Investigator discretion that enrollment on the study would pose undo harm or risk to the patient
- •Non-MRI compatible implanted medical device
- •Use of systemic anti-cancer therapy within the previous 3 months
- •Medical contraindication to craniotomy and tumor resection
- •Pathologic confirmation of grade I-II glioma, brain metastasis, or other brain tumor
- •Note: Patients with a history of grade I-II glioma are eligible if they have only received surgery as treatment and now there is concern for transformation to grade III-IV tumor
- •Primary spinal cord glioma or primary brainstem glioma
- •Residual tumor of excessive volume or eloquent location per investigator discretion
- •Patients who are unwilling or unable to comply with study procedures
研究组 & 干预措施
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Temozolomide (Drug)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Stereotactic Biopsy (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Tumor Treating Fields Therapy (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Biopsy (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Therapeutic Conventional Surgery (Procedure)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Radiation Therapy (Radiation)
Treatment (stereotactic biopsy, radiosurgery, surgery)
Patients undergo MRI-guided stereotactic biopsy. Within 14 days of registration, patients undergo either standard of care surgery or radiosurgery in 1 fraction. Within 14 days, patients who underwent radiosurgery then undergo surgery. Within 4-6 weeks, all patients then receive standard of care radiation therapy over 30 fraction and temozolomide daily with or without TTF at the discretion of the treating neuro-oncologist. Additionally, patients undergo MRI and blood sample collection and optional biopsy throughout the study.
干预措施: Radiosurgery (Radiation)
结局指标
主要结局
Proportion of patients experiencing any acute grade 3 or greater unplanned adverse event
时间窗: Up to 4 weeks postoperative radiotherapy
Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The toxicity rate will be estimated using a binomial estimator and a one-sided 95% confidence interval (CI) of the rate will be computed with normal approximation.
Acute clinical toxicity
时间窗: Up to 4 weeks postoperative radiotherapy
Assessed per CTCAE v5.0. The maximum grade for each type of acute adverse events will be recorded for each patient. Data will be summarized as frequencies and relative frequencies by treatment arm. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. Rates will be compared between arms using chi-squared tests.
Maximum tolerated dose (MTD) of preoperative radiosurgery
时间窗: Up to 4 weeks postoperative radiotherapy
After the trial is completed, the MTD will be based on isotonic regression. The dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate will be selected as the MTD. If there are ties, the higher dose level will be selected when the isotonic estimate is lower than the target toxicity rate; and the lower dose level will be selected when the isotonic estimate is greater than or equal to the target toxicity rate.
次要结局
- Radiographic tumor control(At 12 months post-surgery)
- Rate of pseudoprogression(At first post radiation scan)
- Overall survival(At 12 months post-surgery)