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Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer

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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
Information provided by (Responsible Party):
Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven

Brief Summary:
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.

Condition or disease
Head and Neck Neoplasms Xerostomia Deglutition Disorders

Detailed Description:

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
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. toxicity [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients treated with primary (chemo-)radiotherapy for head and neck squamous cell carcinoma up to 70-72 Gy.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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       sandra.nuyts@uzleuven.be   
Principal Investigator: Sandra Nuyts, MD, Ph.D         
Sub-Investigator: Maarten Lambrecht, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Sandra Nuyts, M.D., Ph.D Department of Radiotherapy, UZ Gasthuisberg Leuven


Responsible Party: Dr. Sandra Nuyts, Professor, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01621048     History of Changes
Other Study ID Numbers: s54403
First Posted: June 15, 2012    Key Record Dates
Last Update Posted: March 12, 2013
Last Verified: March 2013

Keywords provided by Dr. Sandra Nuyts, Universitaire Ziekenhuizen Leuven:
Head and Neck Neoplasmsr
Deglutition Disorders

Additional relevant MeSH terms:
Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases