Tests heat treatment with radiation for cancers that have returned after earlier radiotherapy
Tests heat added to repeat radiation in adults whose cancer has come back.
Key facts
- Who runs it
- Charite University, Berlin, Germany
- Where
- Berlin, GermanySee the site
- Trial code
- Registry title
- Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 110 people, planned
- Started
- 10 May 2024
- Expected to end
- Jan 2028
- Type of study
- Interventional
- Treatments tested
- loco-regional hyperthermia
- Record updated
- 26 December 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose tumor has come back after earlier radiotherapy. Heat treatment (hyperthermia) is added to a new course of radiotherapy.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Tumor has come back locally, in the region, or in a few places. At most 3 visible tumor lesions. The area can be treated with heat: abdomen, pelvis, arms or legs, spine, or neck lymph nodes.
- Earlier treatment
- Earlier radiotherapy to the same area with a dose above 30 Gy EQD2. A new radiotherapy dose of at least 40 Gy EQD2 is planned.
Main reasons for not taking part
- More than 3 visible tumor lesions
- Brain metastases
- Recurrence could be treated with local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
- Recurrence in the lung, liver or mediastinum
- Reasons against heat treatment, such as serious heart or blood vessel disease, an ICD or large implants at the treatment site
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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)
Who cannot take part
- recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
- contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
- psychiatric disorders that impede proper informed consent
- >3 macroscopic tumor lesion
- brain metastases
- recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
- serious comorbidities with very limited prognosis quo ad vitam
Where in Germany
- Klinik für Radioonkologie und StrahlentherapieBerlin, GermanyContact: Sebastian Zschaeck, M.D.No longer taking part
About the trial
What the trial wants to find out
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
The group in the trial
- HyperthermiaTreatment being tested
Patients will receive 6-8 treatments additional loco-regional hyperthermia concurrent to re-irradiation. Hyperthermia will start on the third day of fractionated radiotherapy and will be given twice per week. According to site of recurrent disease either deep-regional, capacitive or superficial hyperthermia devices may be used.
Treatment: loco-regional hyperthermia
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
- Plain-language title
- Tests heat treatment with radiation for cancers that have returned after earlier radiotherapyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 26 December 2023