This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
patients that present a relapse within the previously irradiated volume can be included in this trial. These patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. According to tumor location hyperthermia can either be performed by microwave or by capacitive devices. The primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
110
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
Klinik für Radioonkologie und Strahlentherapie
Berlin, Germany
Local tumor recurrence
Local tumor recurrence of re-irradiated lesions, calculated with the Kaplan-Meier estimates. Local recurrence after hyperthermic re-irradiation will be compared to time-to recurrence after initial treatment.
Time frame: 3 years
Overall survival
Overall survival after start of re-irradiation
Time frame: 3 years
Progression-free survival
Progression-free survival after start of re-irradiation
Time frame: 3 years
Freedom from distant metastases
Freedom from distant metastases after start of re-irradiation
Time frame: 3 years
Patient reported quality of Life
patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
Time frame: 3 years
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