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Head and Neck NeoplasmsNCT01621048

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

An observational study of Head and Neck Neoplasms and Xerostomia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
0 participants
Where
1 siteBelgium
Study dates
Jun 2012to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated with primary (chemo-)radiotherapy for head and neck squamous cell carcinoma up to 70-72 Gy.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Department of Radiotherapy-Oncology, UZ Gasthuisberg Leuven

    Leuven, 3000

Other trials in Belgium

About this study

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

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.

Read the 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.

Keywords
Head and Neck Neoplasmsr, Radiotherapy, Xerostomia, Deglutition Disorders
Medical subject headings
Head and Neck Neoplasms, Xerostomia, Deglutition Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    toxicity

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01621048
Sponsor's protocol ID
s54403
Status last verified
Mar 2023
First submitted
13 Jun 2012
Last updated
3 Apr 2023
Results posted
No
Data monitoring committee
No

Publications

  • Bourhis J, Overgaard J, Audry H, Ang KK, Saunders M, Bernier J, Horiot JC, Le Maitre A, Pajak TF, Poulsen MG, O'Sullivan B, Dobrowsky W, Hliniak A, Skladowski K, Hay JH, Pinto LH, Fallai C, Fu KK, Sylvester R, Pignon JP; Meta-Analysis of Radiotherapy in Carcinomas of Head and neck (MARCH) Collaborative Group. Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis. Lancet. 2006 Sep 2;368(9538):843-54. doi: 10.1016/S0140-6736(06)69121-6.

    PubMed 16950362

  • Pignon JP, Bourhis J, Domenge C, Designe L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000 Mar 18;355(9208):949-55.

    PubMed 10768432

  • Nuyts S, Dirix P, Clement PM, Poorten VV, Delaere P, Schoenaers J, Hermans R, Van den Bogaert W. Impact of adding concomitant chemotherapy to hyperfractionated accelerated radiotherapy for advanced head-and-neck squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1088-95. doi: 10.1016/j.ijrobp.2008.05.042. Epub 2008 Aug 15.

    PubMed 18707823

  • Machtay M, Moughan J, Trotti A, Garden AS, Weber RS, Cooper JS, Forastiere A, Ang KK. Factors associated with severe late toxicity after concurrent chemoradiation for locally advanced head and neck cancer: an RTOG analysis. J Clin Oncol. 2008 Jul 20;26(21):3582-9. doi: 10.1200/JCO.2007.14.8841. Epub 2008 Jun 16.

    PubMed 18559875

  • Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, Hall E; PARSPORT trial management group. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2011 Feb;12(2):127-36. doi: 10.1016/S1470-2045(10)70290-4. Epub 2011 Jan 12.

    PubMed 21236730

  • Dirix P, Nuyts S. Evidence-based organ-sparing radiotherapy in head and neck cancer. Lancet Oncol. 2010 Jan;11(1):85-91. doi: 10.1016/S1470-2045(09)70231-1.

    PubMed 20129131

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Neoplasms and Xerostomia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

toxicity: EORTC QLQ H&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory. (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01621048, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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