Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Local tumor recurrence
研究概览
简要总结
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
详细描述
patients that present a relapse within the previously irradiated volume can be included in this trial. These patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. According to tumor location hyperthermia can either be performed by microwave or by capacitive devices.
The primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).
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
- •prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9)
- •local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy
- •macroscopic tumor recurrence
- •side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)
- •planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9)
排除标准
- •>3 macroscopic tumor lesion
- •brain metastases
- •recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
- •recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
- •contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
- •psychiatric disorders that impede proper informed consent
- •serious comorbidities with very limited prognosis quo ad vitam
结局指标
主要结局
Local tumor recurrence
时间窗: 3 years
Local tumor recurrence of re-irradiated lesions, calculated with the Kaplan-Meier estimates. Local recurrence after hyperthermic re-irradiation will be compared to time-to recurrence after initial treatment.
次要结局
- Patient reported quality of Life(3 years)
- Overall survival(3 years)
- Freedom from distant metastases(3 years)
- Progression-free survival(3 years)
研究者
Sebastian Zschaeck
MD, PI
Charite University, Berlin, Germany