NCT03126266已完成不适用
ReRAD: A Phase II Canadian Pediatric Brain Tumour Consortium Study of Re-Irradiation as Treatment of Progressive or Recurrent Diffuse Intrinsic Pontine Glioma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 21
- 主要终点
- second progression-free survival
研究概览
简要总结
This is a single-arm, non-randomized study of re-irradiation of diffuse intrinsic pontine glioma (DIPG)
详细描述
Study therapy will consist of radiation therapy (RT) given over 17 treatment days (for 30.6 Gy in fractions of 1.8 Gy) or 20 treatment days (for 36 Gy in 1.8 Gy fractions), depending on the time from completion of the first course of RT. Treatment days will generally be weekdays, not including statutory holidays.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All of these criteria must be met for a patient to be eligible for this study:
- •Each site may accept a patient on study of any age that they have permission to treat and follow on study per their institutional policy.
- •The patient has no evidence of metastases on cranial or spinal MR imaging
- •The patient has received RT in the past, given to a total cumulative dose of <60 Gy; prior radiation using opposed lateral fields, conformal 3-D fields, IMRT or using protons is acceptable
- •At least 180 days have elapsed from the last day of primary RT for DIPG
- •The patient has recovered from all acute and subacute toxicities of prior RT and of chemotherapy, if chemotherapy was utilized in the past
- •The patient has been off all anti-tumour therapy for at least 14 days
- •The patient has a Lansky score of 40% or higher
- •The patient has a life expectancy anticipated to be at least 8 weeks with treatment using re-irradiation, with or without dexamethasone
- •The patient has no uncontrolled medical condition (e.g., seizures, diabetes, infection) that would interfere with the delivery of rRT
- •The patient agrees to not enroll on any other clinical trial of an anti-tumour intervention
- •The patient agrees to report and have recorded the use of all medications taken during ReRAD therapy, from the time of diagnosis of progression or recurrence, then through and after completion of, ReRAD therapy; this includes the use of complementary, alternative and dietary therapies
- •The patient is treated at a site where the study is approved by the local ethics board
- •Males and females of child-bearing potential must agree to use effective birth control measures during rRT
- •Consent, and, if applicable, assent, has been obtained according to institutional standards
排除标准
- •If the patient fulfills any of these criteria, then he or she will not be eligible for the study:
- •Females who are pregnant, due to risks from rRT on the developing fetus.
- •Any patient with a condition that prohibits the planned delivery of rRT as prescribed in this study.
- •Patients who are receiving any other clinical trial of an anti-tumour intervention
结局指标
主要结局
second progression-free survival
时间窗: up to 18 months from the start of re-irradiation
length of time from start of re-irradiation to subsequent progression of disease
次要结局
- overall survival(up to three years from initial diagnosis of DIPG)
研究者
研究点 (21)
Loading locations...
相似试验
尚未招募
不适用
RE-irradiation of Diffuse MIdline Glioma paTientsDiffuse Midline Glioma, H3 K27M-MutantDiffuse Intrinsic Pontine GliomaDiffuse GliomaPontine TumorsThalamic TumorBrain Tumor, PediatricNCT06093165Rigshospitalet, Denmark59
已完成
1 期
A Phase I/II Study of the Photon Radiosurgery SystemBrain Tumor, RecurrentGlioblastoma MultiformeNCT00179907Ann & Robert H Lurie Children's Hospital of Chicago35
终止
1 期
Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine GliomasBrain CancerBrain Stem TumorsPontine TumorsNCT01058850Paul Graham Fisher3
终止
1 期
Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I)Diffuse Intrinsic Pontine Glioma (DIPG)Brain Stem GliomaNCT03396575University of Florida11
Unknown
1 期
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor LinesDiffuse Intrinsic Pontine GliomaNCT02840123Fundació Sant Joan de Déu10