Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- toxicity of carbon ion re-irradiation
研究概览
简要总结
After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.
In the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity/ safety, local progression-free survival, overall survival and quality-of-life.
详细描述
The incidence of head-and-neck cancer worldwide amounts to around 550.000 cases per year, with male patients affected significantly more often. Common risk factors are smoking, alcohol, viral infections, immunodeficiency or genetic factors. Locally advanced head-and-neck tumors can lead to severe symptoms such as dysphagia, cachexia and tumor pain with a significant decrease of the quality-of-life. The prognosis depends on multiple factors such as TNM-staging, tumor volume, histology, general condition, age and smoking. Further risk factors are positive resection margins, extracapsular extension and perineural invasion. While metastatic spread significantly decreases overall survival, the life-limiting problem in patients with head-and-neck cancer is locally invasive and destructive tumor growth leading to a decrease of the performance status and quality of life. After multimodal therapy of locally advanced head-and-neck tumors, around 30 - 50% of patients will develop local recurrence or locally progressive disease and up to 8% of patients with HNSCC will develop a second primary tumor in the head-and-neck .
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally recurrent / progressive head-and-neck cancer after initial radiation therapy
- •Microscopic or macroscopic tumor after salvage surgery
- •Indication for re-irradiation
- •Completed wound healing after surgical intervention
- •Karnofsky-Performance-Score ≥ 60
- •Age ≥ 18 years
- •Written informed consent (must be available before enrolment in the trial)
- •Ability of subject to understand character and individual consequences of the trial
- •For women with childbearing potential, (and men) adequate contraception
- •Submission of previous radiotherapy records
排除标准
- •Re-irradiation of malignancy in the larynx
- •Diagnosed plasmocytoma, sarcoma or chordoma
- •Previous re-irradiation in-field
- •Time interval < 6 months after initial radiotherapy
- •Distant metastases (except pulmonary metastases)
- •Patients who have not recovered from acute toxicities of prior therapies
- •Refusal of the patients to take part in the study
- •Pregnant or lactating women
- •Known carcinoma <5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- •Participation in another clinical study or observation period of competing trials, respectively
研究组 & 干预措施
C12 irradiation
Evaluation of Safety and Toxicity of C12 ion reirradiation
干预措施: C12 re-irradiation (Radiation)
Photon irradiation
Evaluation of Safety and Toxicity of photon re-irradiation
干预措施: Photon re-irradiation (Radiation)
结局指标
主要结局
toxicity of carbon ion re-irradiation
时间窗: 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
safety of carbon ion re-irradiation
时间窗: 6 month
the rate of patients with an acute/subacute toxicity CTCAE v5.0 ≥ grade 3
次要结局
- progression-free survival(12 month)
- Overall survival(12 month)
- Score on EORTC QLQ H&N35 Quality of life questionaire(within 12 month after re-irradiation)
- Score on EORTC QLQ C30 Quality of life questionaire(within 12 month after re-irradiation)
研究者
Juergen Debus
Head of department
University Hospital Heidelberg
