Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: loco-regional hyperthermia.
- Who it may be relevant to
- Registry conditions: Recurrent Cancer, Prostate Cancer, Cervical Cancer, Anal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Device loco-regional hyperthermia
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
Primary outcome measures
- Local tumor recurrence [Time frame: 3 years]
Secondary outcome measures (4)
- Overall survival [Time frame: 3 years]
- Progression-free survival [Time frame: 3 years]
- Freedom from distant metastases [Time frame: 3 years]
- Patient reported quality of Life [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Klinik für Radioonkologie und Strahlentherapie — Berlin
Identifiers
NCT: NCT04889742 · HETERERO