Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Trial ID: NCT04889742

Interventional - Phase 2 - Not yet recruiting

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

Conditions

• Recurrent Cancer
• Prostate Cancer
• Cervical Cancer
• Anal Cancer
• Sarcoma
• Rectal Cancer
• Neuroendocrine Tumors
• Esophageal Cancer
• Pancreas Cancer
• Squamous Cell Carcinoma

Interventions

• loco-regional hyperthermia

Eligibility

Inclusion criteria

• 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 criteria

• \>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

Sponsor

Charite University, Berlin, Germany

Source: ClinicalTrials.gov

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