Breast cancer, radiation therapy, tattoo-free surface-guided radiation
Conditions
Interventions
Group 1: Patient positioning and the planning CT scan will be performed non-study specific in supine position with arms raised above the head with standard Wingstep® immobilization device. Patients un
only the tattoo-free positioning procedure constitutes a study-related intervention. All other aspects of treatment are consistent with standard clinical practice.
Sponsors
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patients with an indication for image-guided, postoperative photon radiotherapy of the breast or chest wall with regional nodal irradiation -ECOG Performance status = 2 -ability of subject to understand character and individual consequences of the clinical trial -written informed consent
Exclusion criteria
Exclusion criteria: -pregnant or lactating women -comorbidities or anatomical reasons that prevent a standard positioning in Wingstep® immobilization device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint (binary, acceptable criteria reached yes/no) is based on the proportion of treatment fractions meeting the predefined acceptable setup accuracy criteria. Technical practicability for an acceptable setup accuracy will be concluded, if =90% of treatment fractions meet the predefined criteria of residual setup deviation =6 mm in all translational directions following precise surface-guided alignment, as verified by daily cone-beam CT (CBCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| For secondary objectives, including setup time evaluation, data will be reported descriptively (mean with standard deviation or median with interquartile range or absolute and relative frequencies) and repeated-measures ANOVA for patient-reported outcome using numeric rating scales. | — |
Countries
Germany
Contacts
Public ContactEva Meixner
Universitätsklinikum Heidelberg, Radiologische Klinik, RadioOnkologie und Strahlentherapie
Outcome results
None listed