A Phase II Trial of Surgery and Fractionated Re-Irradiation for Recurrent Ependymoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 3-year Progression-free Survival Rate
研究概览
简要总结
The primary purpose of this study is to investigate whether surgery and re-irradiation will help treat ependymoma that has come back after initial treatment. The combined doses of the first and second courses of radiation are higher than what is usual standard of care. The investigators will study the effects and side effects of surgery and re-irradiation. They will also evaluate and study tumor tissue and blood to learn more about the tumor and how it does or does not respond to treatments and will use magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to see if they can predict tumor response and tumor recurrence.
Participants will be followed for up to 5 years following enrollment. Evaluations during radiation therapy will be done weekly while receiving therapy for up to 7 weeks. Other evaluations will be done at enrollment, every 4 months from enrollment through 3 years, and every 6 months during the 4th and 5th year.
详细描述
Stratification for treatment will be determined when radiation therapy planning is initiated. Patients will be stratified for outcome according to diagnosis and prior therapy.
- Stratum 1 (initial pattern of failure is local); disease confined to primary site; age >12 months at time of enrollment to < 21 years. Treatment: focal irradiation.
- Stratum 2 (initial pattern of failure is metastatic); neuraxis metastatic disease without equivocal evidence of local failure; age > 36 months at time of enrollment to < 21 years. Treatment: craniospinal irradiation.
- Stratum 3 (Initial pattern of failure is both local and metastatic): neuraxis metastatic disease with unequivocal evidence of local failure; age > 36 months at time of enrollment to < 21 years. Treatment: craniospinal irradiation.
- Stratum 4 (initial pattern of failure is local): disease confined to primary site, age >36 months at time of enrollment to <21 years; tumor shows presence of 1g gain. Treatment: craniospinal irradiation (optional).
PRIMARY OBJECTIVE:
- To prospectively estimate the progression-free and overall survival distributions for children and young adults with recurrent ependymoma treated with a second course of irradiation while monitoring for excessive central nervous system necrosis.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Progressive intracranial ependymoma after prior focal irradiation
- •Patients aged 1-21 years at the time of enrollment
- •Adequate performance status (ECOG < 3) and research participant does not require mechanical ventilation
- •Interval from start of initial radiation therapy to enrollment > 9 months
排除标准
- •Prior craniospinal irradiation
- •Pregnant women are excluded from enrollment on this study because radiation therapy is an agent with the potential for teratogenic or abortifacient effects
- •Any patient with both metastatic ependymoma and age < 3 years at the time of enrollment
研究组 & 干预措施
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Irradiation (Radiation)
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Surgery (Procedure)
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^8F-Fluorodeoxyglucose (Drug)
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^1C-methionine (Drug)
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Photon therapy (Device)
Stratum 1: Local Failure
Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Treatment is surgery and a second course of focal irradiation. The total dose for the second course of irradiation will be 54Gy.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Proton therapy (Device)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Irradiation (Radiation)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Surgery (Procedure)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^8F-Fluorodeoxyglucose (Drug)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^1C-methionine (Drug)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Photon therapy (Device)
Stratum 2: Metastatic Failure
Participants exhibit an initial pattern of failure that is metastatic (neuraxis metastatic disease without equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation. Craniospinal irradiation (36-39.6Gy) will include focal boost treatment of metastatic sites (54-59.4Gy) depending on location, extent of resection and target volume.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Proton therapy (Device)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Irradiation (Radiation)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Surgery (Procedure)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^8F-Fluorodeoxyglucose (Drug)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^1C-methionine (Drug)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Photon therapy (Device)
Stratum 3: Local and Metastatic Failure
Participants exhibit an initial pattern of failure that is both local and metastatic (neuraxis metastatic disease with equivocal evidence of local failure). Treatment is surgery and craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Proton therapy (Device)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Irradiation (Radiation)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Surgery (Procedure)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^8F-Fluorodeoxyglucose (Drug)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: ^1^1C-methionine (Drug)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Photon therapy (Device)
Stratum 4: Local Failure
Local Failure Participants exhibit an initial pattern of failure that is local (disease confined to primary site). Age is >36 months at time of enrollment to <21 years. Tumor shows presence of 1q gain. Treatment is optional craniospinal irradiation.
Participants may receive one or both: Photon therapy or proton therapy.
Participants receive ^1^8F-fluorodeoxyglucose and ^1^1C-methionine to aid in tumor visualization.
干预措施: Proton therapy (Device)
结局指标
主要结局
3-year Progression-free Survival Rate
时间窗: 2 years follow-up after initiation of radiation therapy for the last patient enrolled
To prospectively estimate the progression-free distribution for children and young adults with recurrent ependymoma treated with a second course of irradiation.
3-year Overall Survival Rate
时间窗: 2 years follow-up after initiation of radiation therapy for the last patient enrolled
OS was calculated from the date of initial radiation therapy to date of death or date of last contact for the patients who were treated with RT. The event of interest was death.
次要结局
- Mean Change in Overall Coordination(Fine motor coordination (finger and hand coordination).)
- Incidence Rate of Neurological Deficits(Through 5 years after initiation of second course of irradiation)
- Incidence Rate of Ophthalmological Deficits(Through 5 years after initiation of second course of irradiation)
- Incidence Rate of Audiological Deficits(Through 5 years after initiation of second course of irradiation)
- Incidence Rate of Endocrine Deficits(Through 5 years after initiation of second course of irradiation)
- Number of Neurocognitive Deficits(Through 5 years after initiation of second course of irradiation)
- Mean Change in Quality of Life by Treatment Arm(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Measured Task Sets(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Physical Function(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Body Mass Index (kg/m2)(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Waist/Hip Ratio (cm/cm)(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Ankle Dorsiflexion(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Overall Flexibility in cm(Baseline through 5 years after initiation of radiation therapy)
- Proportion Change in Balance(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Fine Motor Coordination(Baseline through 5 years after initiation of radiation therapy)
- Mean Change of Lower Extremity Strength and Power(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Hand Grip Strength(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Resting Energy Expenditure(Baseline through 5 years after initiation of radiation therapy)
- Mean Change in Cardiopulmonary Exercise Test (CPET)(Baseline through 5 years after initiation of radiation therapy)
- Longitudinal Change of Size (or Extent if Leptomeningeal Dissemination) of Residual Tumor(Baseline through 5 years after initiation of radiation therapy)
- Longitudinal Change of Incidence and Severity of Structural Effects of Normal Brain(Baseline through 5 years after initiation of radiation therapy)
- Longitudinal Change in Gray and White Matter Tissues(Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years)
- Longitudinal Change of Individual Variation and Risk Factors in Gray and White Matter Tissues(Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years)
- Change Over Time in Imaging Metrics(Baseline to recovery of gray and white matter tract injury, up to a maximum of 5 years)