A Phase II Randomized Study Assessing the Efficacy of Proton Craniospinal Irradiation (CSI) vs Involved-field Photon Radiation Therapy for Leptomeningeal Metastases From Solid Tumor Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- CNS progression free survival
研究概览
简要总结
The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy.
Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology
- •Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
- •Patients of all ages
- •KPS ≥ 60 for participants ≥ 16 years old, and Lansky ≥ 60 for participants < 16 years old
- •For adult patient, the patient/ legally authorized representative is able to provide informed consent. For pediatric patient, a parent is able to provide informed consent.
- •Adequate bone marrow function:
- •Hemoglobin > 8g/dL
- •Absolute neutrophil count >1,000/mm
- •Platelet count > 100,000/mm
- •Female subjects must either be of non-reproductive potential (i.e. pediatric patients, OR postmenopausal by history [≥ 60 years old, or with no menses for >1 year without an alternative medical cause], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment.
- •Patient at reproductive potential must agree to practice an effective contraceptive method.
排除标准
- •Patient with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy
- •Patient with extensive systemic disease and without reasonable systemic treatment options
- •Patient who is unable to undergo MRI brain and spine with gadolinium contrast
- •Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
- •Pregnant or lactating women.
研究组 & 干预措施
Proton CSI Followed by Standard of Care (NSCLC & Breast)
Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Proton Craniospinal Irradiation (CSI) (Radiation)
Proton CSI Followed by Standard of Care (NSCLC & Breast)
Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Neurocognitive Assessment (Other)
Proton CSI Followed by Standard of Care (NSCLC & Breast)
Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: MDASI-BT and MDASI-SP (Other)
Standard of Care
Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Involved-field Photon Radiation Therapy (Radiation)
Standard of Care
Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Neurocognitive Assessment (Other)
Standard of Care
Involved field photon RT including WBRT and/or focal spine RT (30Gy in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: MDASI-BT and MDASI-SP (Other)
Proton CSI Followed by Standard of Care (Other Solid Tumors)
(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Proton Craniospinal Irradiation (CSI) (Radiation)
Proton CSI Followed by Standard of Care (Other Solid Tumors)
(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: Neurocognitive Assessment (Other)
Proton CSI Followed by Standard of Care (Other Solid Tumors)
(Exploratory arm) Patients with solid tumor malignancies other than NSCLC or breast cancer will be enrolled to the exploratory proton CSI arm (Arm C) and will not undergo randomization. Proton CSI (30Gy [RBE] in 10 fractions) followed by standard of care systemic treatments for leptomeningeal metastases per physician choice.
干预措施: MDASI-BT and MDASI-SP (Other)
结局指标
主要结局
CNS progression free survival
时间窗: 2 years
For Arm A and Arm B, which will be defined as the duration of time from the date of randomization to the time of progression of disease or death, whichever occurs first. The baseline imaging study will be the diagnostic imaging obtained at study entry.
次要结局
- overall survival (OS) (Arm A and Arm B)(2 years)