About this trial
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9)
local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy
macroscopic tumor recurrence
side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)
Disqualifiers
>3 macroscopic tumor lesion
brain metastases
recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
Trial design
Single group
Treatments tested in this trial
loco-regional hyperthermia
Deviceloco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall survival
Overall survival after start of re-irradiation
Progression-free survival
Progression-free survival after start of re-irradiation
Freedom from distant metastases
Freedom from distant metastases after start of re-irradiation
Patient reported quality of Life
patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: