Clinical trial · Observational
Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer
Evaluation of Treatment Related Toxicity After Radiotherapy for Head and Neck Cancer and Correlation With Dose to Organs at Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Deglutition Disorders | — | UNRESOLVED | — |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Xerostomia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- toxicity: EORTC QLQ H&N35 questionnaire, the university of Michigan Xerostomia questionnaire (XQ) and the MD Anderson Dysphagia Inventory.
- timeFrame
- 5 years
- description
- toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDBourhis 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. PMID 16950362
- BACKGROUNDPignon 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. PMID 10768432
- BACKGROUNDNuyts 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. PMID 18707823
- BACKGROUNDMachtay 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. PMID 18559875
- BACKGROUNDNutting 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. PMID 21236730