Patients will receive in addition to standard histology analysis also the PDC- based drug screening.
Patients will receive in addition to standard histology analysis also the PDC- based drug screening. The PDC-based drug screening will be performed only in accordance with the approved Performance Study Plan on subjects who have signed an informed consent form. Execution of the PDC-based drug screening is limited to the approved study investigators. Based on the results of the PDC-based drug screening, a molecular tumor board will formulate a personalized treatment approach. The personalized treatment recommendation will be communicated to the patient. Application of adjuvant / maintenance therapy will be evaluated to evaluate the proportion of patients scheduled for a reduced course of radio(-chemo)therapy fit enough to receive at least one day of systemic therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics
AKH Vienna, Department for Internal Medicine I, Oncology
Vienna, State of Vienna, Austria
RECRUITINGPercentage of patients
Percentage of patients receiving at least one day of maintenance systemic therapy in the timeframe of 4-6 weeks after completion of a short course radio(-chemo)therapy (40 Gy in 15 fractions)
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
PDC-based drug screening
Assess feasibility of a PDC-based drug screening approach in a multi-center study hroughout Austria and within the timeframe short course radio(-chemo)therapy (40 Gy in 15 fractions)
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
Quality of life assessment
Quality of life assessment based on verified questionnaires
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
Neurocognitive function
Assess the neurocognitive function using the NANO scale (neurological assessment in neuro- oncology)
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
Overall survival
Assess the overall survival
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
Progression free survival
Assess the progression free survival
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years
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Geriatric screening tools
Geriatric vulnerability will be assessed using the Geriatric-8 (G8) and Vulnerable Elders Survey 13 (VES-13) screening tools.
Time frame: From date of enrollment until the last follow up or the date of death from any causes, whichever came first, assessed up to 3 years