SarcomaPhase 2HyperTETNCT02359474
Hyper-Thermia Enhanced Anti-tumor Efficacy of Trabectedin
A Phase 2 study testing Trabectedin and DNA double-strand breaks in people with Sarcoma, run by Ludwig-Maximilians - University of Munich at 5 sites in Germany.
Trial summary
This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Trabectedin and DNA double-strand breaks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesGermany
- Study dates
- 19 Dec 2014to Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Age > 18 years
- Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
- Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT
- Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
- After macroscopic incomplete resection or marginal resection (tumor-free margins < 1 cm)
- Prior chemotherapy, including anthracyclines with/without ifosfamide (with or without RHT) or patients who cannot be given these medicines
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- At least one tumor manifestation which is eligible for hyperthermia
- Performance status (ECOG) 0,1 or 2
- More than 3 weeks from last treatment
- Neutrophil count ≥ 1,5 G/l, hemoglobin ≥ 9 g/dl, platelets ≥ 100 G/l
- Albumin ≥ 25 g/l, total bilirubin ≤ 1 x ULN, ALT/AST ≤ 2.5 x ULN, AP ≤ 2.5 x ULN, Cockroft and Gault's calculated creatinine clearance ≥ 30 ml/min, CPK ≤ 2.5 x ULN
- Patients with the ability to follow study instructions and likely to attend and complete all required visits
- Written informed consent of the subject
Who cannot join
- Uncontrolled infection (e.g. active viral hepatitis)
- Unstable cardiac status
- Peripheral neuropathy > grade 2
- Known or persistent abuse of medications, drugs or alcohol
- Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
- Prior therapy with Tr or known history of hypersensitivity to drugs with a similar chemical structure
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- Pregnancy or breast-feeding
- Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration
- Uncontrolled CNS-metastases
- Medical or technical impossibility for hyperthermia to heat the major target lesion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Helios Klinikum Bad Saarow
Bad Saarow
Charité - Universitätsmedizin Berlin
Berlin
Helios Klinikum Berlin-Buch
Berlin
Universitätsklinikum Erlangen
Erlangen
Ludwig-Maximilians University of Munich, Klinikum Großhadern
Munich, Bavaria, 81377
About this study
Official title: Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
This trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.
- Conditions
- Sarcoma
- Being tested
- Trabectedin, DNA double-strand breaks
- Keywords
- high-risk soft tissue sarcoma, trabectedin
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabectedinDrug
Also called Yondelis
DNA double-strand breaksGenetic
The rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and "danger signals" are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018).
| Study group | Role | What they receive |
|---|---|---|
| Trabectedin with regional hyperthermia | Experimental | Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease.
Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs). Receives: Drug: Trabectedin; Genetic: DNA double-strand breaks |
| Trabectedin | Active comparator | Trabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. Receives: Drug: Trabectedin; Genetic: DNA double-strand breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
Measured: planned after 46 events after start of recruitment which are expected to occur after 27 month
Secondary outcomes (3)
Radiological response according to RECIST
Measured: planned after 46 events after start of recruitment which are expected to occur after 27 month
Overall Survival (OS)
Measured: planned after 46 events after start of recruitment which are expected to occur after 27 month
Treatment related toxicity (hematological, renal, hepatic, others)
Measured: planned after 46 events after start of recruitment which are expected to occur after 27 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start19 Dec 2014
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Kampmann, Ludwig-Maximilians - University of Munich
- Investigators
- Rolf Issels, MD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359474
- Sponsor's protocol ID
- HyperTET
- Acronym
- HyperTET
- Status last verified
- Feb 2023
- First submitted
- 10 Nov 2014
- Last updated
- 28 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabectedin Combined With Regional Hyperthermia as Second Line Treatment for Adult Patients With Advanced Soft-tissue Sarcoma
- ClinicalTrials.gov ID
- NCT02359474
- Acronym / sponsor ID
- HyperTET / HyperTET
- Conditions
- Sarcoma
- Keywords
- high-risk soft tissue sarcoma, trabectedin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 19 Dec 2014 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- 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 trial compares trabectedin alone to trabectedin in combination with regional hyperthermia in patients with high-risk soft tissue sarcoma. The study is designed to demonstrate a significant benefit for sarcoma-therapy by adding regional hyperthermia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabectedin with regional hyperthermia | Experimental | Drug: Trabectedin, Genetic: DNA double-strand breaksTrabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. Additional treatment with regional hyperthermia (RHT): RHT treatment of the tumor area and the surrounding tissue (41-44°C for 60 min treatment time) is applied at the end of Trabectedin infusion (+/- 4 hrs). |
| Trabectedin | Active comparator | Drug: Trabectedin, Genetic: DNA double-strand breaksTrabectedin 1.5 mg/m², 24 hrs continuous i.v. infusion, repetition after 21 days, until progress of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age > 18 years
- Histologically confirmed STS (primary or recurrent), except: Ewing sarcoma, osteosarcoma, skeletal chondrosarcoma (extraskeletal chondrosacomas are included), GIST, dermatofibrosarcoma protuberans, malignant mesothelioma, rhabdomyosarcoma
- Patients after failure of first-line chemotherapy (anthracyclines with/without ifosfamide) with or without RHT
- Progressive or recurrent tumor which is unresectable or only resectable with adverse functional outcome
- After macroscopic incomplete resection or marginal resection (tumor-free margins < 1 cm)
Key exclusion criteria (10 listed)
- Uncontrolled infection (e.g. active viral hepatitis)
- Unstable cardiac status
- Peripheral neuropathy > grade 2
- Known or persistent abuse of medications, drugs or alcohol
- Other malignancy during the last 5 years (exclusion of basal cell carcinoma or adequately treated cervical carcinoma in situ)
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 |
|---|---|---|
| TrabectedinAlso: Yondelis | Drug | Trabectedin, Trabectedin with regional hyperthermia |
| DNA double-strand breaksThe rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and "danger signals" are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018). | Genetic | Trabectedin, Trabectedin with regional hyperthermia |
Primary outcome
Progression-free Survival (PFS)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
3 secondary outcomes
Radiological response according to RECIST
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Overall Survival (OS)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Treatment related toxicity (hematological, renal, hepatic, others)
Time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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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. This study is not recruiting at the moment.
Rolf Issels, MD principal investigator
Ludwig-Maximilians - University of Munich
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trabectedin and DNA double-strand breaks in people with Sarcoma, run by Ludwig-Maximilians - University of Munich at 5 sites 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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: planned after 46 events after start of recruitment which are expected to occur after 27 month). 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 28 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.