Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT01621048|
Recruitment Status : Unknown
Verified March 2013 by Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : June 15, 2012
Last Update Posted : March 12, 2013
|Condition or disease|
|Head and Neck Neoplasms Xerostomia Deglutition Disorders|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer and Correlation With Dose to Organs at Risk|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2016|
- toxicity [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621048
|Department of Radiotherapy-Oncology, UZ Gasthuisberg Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Sandra Nuyts, MD phD firstname.lastname@example.org|
|Principal Investigator: Sandra Nuyts, MD, Ph.D|
|Sub-Investigator: Maarten Lambrecht, MD|
|Principal Investigator:||Sandra Nuyts, M.D., Ph.D||Department of Radiotherapy, UZ Gasthuisberg Leuven|