Stereotactic Biopsy Split-Course Radiation Therapy - Diffuse Midline Glioma (SPORT-DMG)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Time to progression
研究概览
简要总结
This phase II trial studies the clinical outcomes of hypofractionated radiation therapy in patients with diffuse midline gliomas. This study aims to change the way radiation is delivered, from giving 6 weeks of radiation all at once to giving 2 weeks of radiation. This may determine if there is a difference in the outcome of the treatment, and most importantly, the patients' quality of life.
详细描述
PRIMARY OBJECTIVE:
I. To determine that 10-month overall survival (OS) rate for the hypofractionated radiation course of 25 Gy in 10 fractions in patients with diffuse midline glioma of the pons is superior to the low-end historical control (Survival rate of 40% at 10 months when calculating from time of enrollment) based on the current standard of care (54 GY in 30 fractions).
SECONDARY OBJECTIVES:
I. To evaluate the quality of life outcomes for patients with diffuse midline gliomas of the pons.
II. To estimate the time to progression after the second hypofractionated radiation course of 25 Gy in 10 fractions, calculated from date of registration and separately from primary tumor diagnosis date.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 1 year(s) old (no maximum age)
- •Radiologic appearance of diffuse midline glioma of the pons, including diffuse infiltration of >= 50% of the pons on MRI, with or without extension to the midbrain and/or medulla oblongata with at least 1 of the 3 brainstem symptoms (cranial nerve deficit, long tract sign, or cerebellar sign)
- •If all features of this clinicoradiologic criteria are met, then patients can continue on protocol with or without a biopsy
- •If all features of this clinicoradiologic criteria are not met, patients must receive a brainstem lesion biopsy to be treated on protocol. If this cannot be completed, patients will be withdrawn from the study
- •If biopsy has already been completed at an outside institution, the outside pathology report will be reviewed ahead of trial enrollment. The pathology specimen will then be sent to Mayo Clinic for further review, but will not delay study enrollment
- •Able to undergo MRI Brain
- •Negative urine pregnancy test completed =< 7 days prior to registration, for women of childbearing potential only
- •Primary language of English or Spanish for patients and their caregiver
- •Patient or caregiver willing and able to provide written informed consent
- •Caregiver able to complete questionnaires by themselves or with assistance
- •Willing to return to enrolling institution for follow-up during the active monitoring phase of the study
排除标准
- •Any patient who has received previous radiation to the brain
- •Any patient who has received previous chemotherapy
- •Any patient with a diagnosis of neurofibromatosis type 1 or 2 (NF1 or NF2)
- •Any of the following:
- •Pregnant women
- •Nursing women
- •Women of childbearing potential who are unwilling to employ adequate contraception
- •Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Other active malignancy =< 5 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix
- •NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
- •Patients > 16 years with an Eastern Cooperative Oncology Group (ECOG) score >= 4 and patients =< 16 years with a Lansky play scale =< 20
- •NOTE: All novel therapeutic interventions, including but not limited to dordaviprone, are allowed for patients who enroll on the clinical trial
研究组 & 干预措施
Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.
干预措施: Computed Tomography Scan (Procedure)
Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.
干预措施: Questionnaire Administration (Other)
Treatment (hypofractionated RT)
Patients undergo hypofractionated RT over 10 fractions. Patients who achieve progression undergo up to 2 retreatment courses. Patients undergo MRI and CT scan throughout the study.
干预措施: Hypofractionated Radiation Therapy (Radiation)
结局指标
主要结局
Time to progression
时间窗: From date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy, assessed up to 3 years
The Wilcoxon Signed-Rank Tests for Non-Inferiority was utilized from PASS software for this design.
Time to progression
时间窗: At 10 months
Defined as the time from date of diagnosis to the date of radiographic or clinical progression following second course of hypofractionated radiation therapy.
Overall Survival (OS) at 10 months
时间窗: Up to 6 years
OS is defined as the time from date of study registration until death due to any cause.
次要结局
- Quality of Life Measurement - PedsQL (children under 18)(Baseline up to 3 years)
- Quality of Life Measurement - NFBrSI-24(Baseline up to 3 years)
- Progression free survival(Up to 3 years)
- FACT-General Family/Caregiver Questionnaire (FACT-G)(Up to 3 years)
- Overall survival(Up to 3 years)
- Incidence of adverse events(Up to 3 years)
- Time to second progression(Up to 6 years)