Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent Cancer
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Local tumor recurrence
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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 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).
Investigators
Sebastian Zschaeck
MD, PI
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Local tumor recurrence
Time Frame: 3 years
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
- Patient reported quality of Life(3 years)
- Overall survival(3 years)
- Freedom from distant metastases(3 years)
- Progression-free survival(3 years)