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

18 Years
Open (Enrolling)
Head and Neck Neoplasms, Xerostomia, Deglutition Disorders

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Trial Information

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

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.

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

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:


Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Sandra Nuyts, M.D., Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiotherapy, UZ Gasthuisberg Leuven


Belgium: Ethics Committee

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Head and Neck Neoplasms
  • Xerostomia
  • Deglutition Disorders
  • Head and Neck Neoplasmsr
  • Radiotherapy
  • Xerostomia
  • Deglutition Disorders
  • Neoplasms
  • Deglutition Disorders
  • Head and Neck Neoplasms
  • Xerostomia