hoofd-hals tumoren head and neck cancer
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Intended curative primary or postoperative radiotherapy for cancer of the head and neck, either or not combined with systemic treatment (chemotherapy or cetuximab); - Suitable for treatment on LINAC E (with cone beam CT); - Age >18 years; - WHO performance status 0-2; - Women of childbearing potential must not be pregnant or lactating; - Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
Exclusion criteria
Exclusion criteria: Patients with postoperative wound healing problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the actual given dose. The actual given dose is the dose administered to the patient during treatment, taking into account patient positioning accuracy and patient deformations. This actual given dose will in general deviate from the planned dose that was calculated based on the planning CT only. The actual given dose for the two different groups will be calculated and compared to the planned dose. The dose distributions of the following structures will be taken into account: - Gross Tumour Volumes (GTVprimary tumour and GTVlymph node metastases) - Clinical Target Volumes (CTV70 and CTV54.5) - Planning Target Volumes (PTV70 and PTV54.5) - Spinal cord - Parotid glands (ipsilateral and contralateral) - Submandibular glands (ipsilateral and contralateral) - Pharyngeal constrictor muscles (superior, medium and inferior) - Thyroid gland | — |
Secondary
| Measure | Time frame |
|---|---|
| The first secondary endpoint is dose calculations on CBCT data. A more sophisticated and efficient method to calculate the actual given dose from the CBCT scans will be developed. The CBCT images are acquired on the treatment table of the linac, just before start of treatment. Therefore, dose calculations based on the CBCT images correspond better with the actual dose distribution than calculations based on repeated CT scans. However, at the moment the dose calculations based on CBCT scans are not as accurate as those based on conventional CT scans. This is caused by the different imaging technique that is used for CBCT*s resulting in less image quality than a conventional CT. Using Deformable Image Registration (DIR) techniques will make it possible to deform the planning CT to obtain new CT images with the anatomical information of the CBCT scan and the image quality of a conventional CT. The results obtained with this method will be validated with the results obtained from the repeated CT-scans. The second secondary endpoint is the positioning accuracy. In head and neck patients, a curative treatment course generally consists of 35 treatment fractions in 6 to 7 weeks. The current procedure is to make CBCTs on the first 4 treatment fractions and subsequently weekly. Based on the findings of these images, inaccuracies are calculated in terms of standard deviations and standard errors and translated into positions corrections according to a standardised protocol. The following endpoints regarding repositioning accuracies will be assessed: - Translations (cranial-caudal, posterior-anterior and left-right) - Rotations (Roll, yaw and pitch) For the purpose of this study, position accuracies will be calculated for both groups. This is part of the current standard procedure and does not require extra patient burden. | — |
Countries
Netherlands
Outcome results
None listed