跳至主要内容
临床试验/NCT01621048
NCT01621048撤回不适用

Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer and Correlation With Dose to Organs at Risk

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
toxicity: EORTC QLQ H&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory.

研究概览

简要总结

Radiotherapy plays an important role in the curative treatment of head and neck cancer. This treatment however is associated with significant acute and late toxicity with xerostomia and dysphagia severely implicating the patient's quality of life. With highly conformal radiotherapy techniques it is possible to decrease de dose to the organs at risk while maintaining adequate doses to the tumour. In order to adequately register the effect of these techniques it is imperative to obtain standardized information on the acute and late treatment effects. With this study the investigators want to evaluate this toxicity using standardized and validated questionnaires during follow-up. This data will then be correlated to the doses delivered to the specific organs at risk.

详细描述

Introduction Radiotherapy is one of the main curative treatment options in advanced head and neck cancer. With the introduction of altered fractionation schedules and concurrent chemotherapy locoregional control numbers and overall survival have improved significantly. This has come at the cost of excess in acute and late toxicity. The steep dose gradients associated with more conformal radiotherapy techniques such as intensity modulated radiotherapy (IMRT) allows us to maintain adequate coverage of the target volume while reducing the dose to the surrounding normal tissues, thus potentially sparing these from excess acute and late toxicity. However to accurately evaluate the value of these new techniques documentation of treatment related toxicity and quality of life is essential. Standardized quality of life scoring systems have been developed for this purpose. Especially xerostomia is very hard to evaluate, although it remains an important issue in the follow-up of these patients.

Purpose In this study the investigators want to analyze treatment related toxicity, with special emphasis on xerostomia and dysphagia in patients treated with radiotherapy for head and neck cancer by presenting them with standardized quality of life questionnaires at well defined points after treatment (2 months, six months, one year ,two years after RT). The result of these questionnaires will then be correlated to treatment data.

Study Design The investigators will include all patient which are in follow-up after primary (chemo-)radiotherapy for head and neck cancer for a period 4 years. At well defined time points after primary (chemo-)radiotherapy for head and neck cancer the investigators will ask the patient to fill in standardized questionnaires compromising of the EORTC QLQ H&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory. The treating physician will score the toxicity using the RTOG/EORTC late toxicity scoring system and the functional oral intake scale (FOIS).

This toxicity data will then be analyzed and correlated with treatment data. Special interest will go to the relationship between the presence of xerostomia and the doses delivered to subvolumes of the parotid glands, the submandibular glands and oral cavity.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx.
  • Stage T1-4,N0-3; for cancer of the glottis T3-4 or TxN1-3
  • Decision for curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors.
  • >18 years of age

排除标准

  • Previous surgery of the primary tumor or lymph nodes
  • Tumour recurrence, locoregional or distant
  • Mental condition rendering the patient unable to understand or fill in the questionnaires

结局指标

主要结局

toxicity: EORTC QLQ H&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory.

时间窗: 5 years

toxicity

次要结局

未报告次要终点

研究者

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

Dr. Sandra Nuyts

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (1)

Loading locations...

相似试验