Recurrent CancerPhase 2HETERERONCT04889742
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
A Phase 2 study testing loco-regional hyperthermia in people with Recurrent Cancer and Prostate Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Cancer, Prostate Cancer, Cervical Cancer
- What is being tested?
- loco-regional hyperthermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- 10 May 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- >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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Klinik für Radioonkologie und Strahlentherapie
Berlin, 13353
Sebastian Zschaeck, M.D.
About this study
This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.
Read the 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).
- Conditions
- Recurrent Cancer, Prostate Cancer, Cervical Cancer, Anal Cancer, Sarcoma, Rectal Cancer
- Being tested
- loco-regional hyperthermia
- Keywords
- re-irradiation, hyperthermia, local recurrence, hyperthermic
- Medical subject headings
- Recurrence, Prostatic Neoplasms, Uterine Cervical Neoplasms, Anus Neoplasms, Sarcoma, Rectal Neoplasms, Neuroendocrine Tumors, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loco-regional hyperthermiaDevice
loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia | Experimental | 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. Receives: Device: loco-regional hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor recurrence
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.
Measured: 3 years
Secondary outcomes (4)
Overall survival
Overall survival after start of re-irradiation
Measured: 3 years
Progression-free survival
Progression-free survival after start of re-irradiation
Measured: 3 years
Freedom from distant metastases
Freedom from distant metastases after start of re-irradiation
Measured: 3 years
Patient reported quality of Life
patient reported quality of life measured by the EORTC qlq-c30 questionnaire.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start10 May 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Zschaeck, Charite University, Berlin, Germany
- Investigators
- Sebastian Zschaeck, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889742
- Sponsor's protocol ID
- HETERERO
- Acronym
- HETERERO
- Status last verified
- Dec 2023
- First submitted
- 12 May 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
- ClinicalTrials.gov ID
- NCT04889742
- Acronym / sponsor ID
- HETERERO / HETERERO
- Conditions
- Recurrent Cancer, Prostate Cancer, Cervical Cancer, Anal Cancer, Sarcoma, Rectal Cancer
- Keywords
- re-irradiation, hyperthermia, local recurrence, hyperthermic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 10 May 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia | Experimental | Device: loco-regional hyperthermiaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- >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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loco-regional hyperthermialoco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices. | Device | Hyperthermia |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sebastian Zschaeck, MD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing loco-regional hyperthermia in people with Recurrent Cancer and Prostate Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Zschaeck, MD (+4930450650764, sebastian.zschaeck@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor recurrence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.