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临床试验/NCT04185974
NCT04185974招募中不适用

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

University Hospital Heidelberg2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年8月25日最近更新:
适应症
干预措施

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

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

Experimental

Evaluation of Safety and Toxicity of C12 ion reirradiation

干预措施: C12 re-irradiation (Radiation)

Photon irradiation

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Debus

Head of department

University Hospital Heidelberg

研究点 (2)

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