Phase II Trial of Normal Tissue Sparing Whole Brain Radiation Therapy (NTS-WBRT) in Patients With Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
研究概览
简要总结
This research is being done to assess the quality of life and symptom burden in participants who receive (normal tissue sparing whole brain radiation therapy (NTS-WBRT).
This research study involves:
- NTS-WBRT (normal tissue sparing whole brain radiation therapy)
- Memantine standard of care drug
详细描述
This is a Phase 2 trial testing the safety and effectiveness of NTS-WBRT (normal tissue sparing whole brain radiation therapy) in treating brain metastases.
NTS-WBRT is a targeted radiation therapy that further reduces radiation dose to tissue that does not need radiation therapy treatment.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
It is expected that about 41 people will take part in this research study.
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
- •Any patient with a solid tumor diagnosis and any number of brain metastasis clinically indicated for cranial irradiation with whole brain radiation therapy
- •Karnofsky Performance Status ≥ 70
- •Prior stereotactic radiosurgery (SRS) permissible per physician discretion
- •Prior craniotomy permissible per physician discretion. Protocol radiation therapy should be initiated ≥2 weeks after craniotomy.
- •Prior partial brain radiation therapy permissible if target volume < 50% brain and per physician discretion
- •Expectant > 6 months survival
- •Ability to understand and the willingness to sign a written informed consent document.
- •Fluency in English, able to complete questionnaires and neurocognitive testing
- •Ability to undergo MRI with gadolinium examination
- •Ability to return for follow-up examinations throughout the course of this study for a maximum of 2 years after radiation treatment completion
- •Any prior, concomitant, or post-radiotherapy systemic therapy is permitted at discretion of treating physicians
- •Negative pregnancy test for premenopausal women
排除标准
- •Leptomeningeal disease (by any one or more of clinical assessment, radiographic assessment, or cerebrospinal fluid study)
- •Prior whole brain radiation therapy
- •Pre-existing or current use of memantine or other NMDA antagonists
- •Known allergy to contrast used in imaging studies and/or inability to have MRI imaging
- •Uncontrolled intercurrent illness that could significantly affect baseline cognitive function as determined by the enrolling clinician, such as symptomatic congestive heart failure, unstable angina pectoris, prior CVA, significant uncontrolled epilepsy or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant or unwilling to use appropriate contraception to prevent pregnancy during the time of radiation therapy
- •Concurrent participation in an investigational systemic therapy protocol.
研究组 & 干预措施
NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine
Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive:
- NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks.
- Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor
干预措施: NTS-WBRT (normal tissue sparing whole brain radiation therapy) (Radiation)
NTS-WBRT (normal tissue sparing whole brain radiation therapy) + Memantine
Participants will be randomly assigned to NTS-WBRT (normal tissue sparing whole brain radiation therapy) administration group and receive:
- NTS-WBRT for 5 days (Monday-Friday) for either 2 or 3 weeks.
- Memantine per standard of care, 1-2x daily for up to 24 weeks Specific participant administration schedules will be determined by study doctor
干预措施: Memantine (Drug)
结局指标
主要结局
Change in Patient Reported Symptom Burden for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
时间窗: 4 Months
Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.
Change in Patient Reported Quality of Life for NTS-WBRT (normal tissue sparing whole brain radiation therapy)
时间窗: 4 Months
Assessed by Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire. Score range is 0-200 and the higher the score, the better the outcome.
次要结局
- Tumor local control Rates between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Otoacoustic Emissions(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Mood between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Neuroendocrine function between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Overall survival (OS) between NTS-WBRT+SIB and NTS-WBRT(The date of randomization to the date of death, or otherwise censored at the last follow-up date for patients still alive up to 24 months)
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0(Up to 24 months)
- Intracranial- Progression Free Survival (PFS) between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Fatigue between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Neurocognitive function between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Pure Tone Average(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Change in Hearing between NTS-WBRT+SIB and NTS-WBRT Assessed by Word Recognition Score(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
- Alopecia Rates between NTS-WBRT+SIB and NTS-WBRT(baseline, 2, 4, 6, 9, 12, 18 and 24 months)
研究者
Helen A. Shih, MD
Principal Investigator
Massachusetts General Hospital