Status:
NOT_YET_RECRUITING
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Recurrent Cancer
Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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)
- planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9)
Exclusion
- \>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)
- contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
- psychiatric disorders that impede proper informed consent
- serious comorbidities with very limited prognosis quo ad vitam
Key Trial Info
Start Date :
May 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04889742
Start Date
May 10 2024
End Date
January 1 2028
Last Update
December 26 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinik für Radioonkologie und Strahlentherapie
Berlin, Germany, 13353