Clinical trial · Interventional
Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE). A Multicenter, Single Arm, Open Label, Phase II Trial
NCT06835049CI-TRIAL-00099846TNT-HYPErecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Soft tissue sarcomas (STSs) are rare cancers with a 5-year survival rate of 60%, and there is no standard treatment for high-risk extremity and trunk STSs (eSTS). A phase III trial suggests that adding moderate regional hyperthermia (HT) to anthracycline-based chemotherapy, followed by surgery and radiotherapy (RT), can improve 10-year overall survival by 10%. This trial aims to optimize treatment by combining the most effective regimens from chemotherapy, HT, RT, and surgery, and will evaluate the feasibility of this new total neoadjuvant treatment (TNT) approach.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Hyperthermia | Other | — | UNRESOLVED |
| Ifosfamide | Drug | Ifosfamide | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Treatment
- description
- Trial treatment consists of 3 neoadjuvant cycles of doxorubicin with either ifosfamide or dacarbazine (the latter only in case of leiomyosarcoma) combined with hyperthermia (HT), followed by radiotherapy (RT) and surgery. Each chemotherapy cycle will last 3 weeks. Trial treatment will last approximately 20 weeks. After surgery, a follow-up period of 36 months per patient is foreseen.
- interventionNames
- Drug: Doxorubicin
- Drug: Ifosfamide
- Drug: Dacarbazine
- Other: Hyperthermia
- Radiation: Radiotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Protocol feasibility rate
- timeFrame
- End of treatment approx. 20 weeks after registration
- description
- PFR defined as percentage of patients who are able to finish the following planned trial treatment parts according to protocol
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Histologically confirmed primary high-risk Soft tissue sarcoma (STS) of extremity or trunk. * High-risk according to the prognostic Sarculator tool: 10-year OS probability \< 60%5. * Resectable tumor: resectability is based on pre-operative imaging and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only a R2 resection is feasible. * Measurable disease per RECIST v1.1. * Diagnostic biopsy is available for the central pathology review. * Candidate for chemotherapy regimen according to protocol. * Candidate for loco-regional HT. * Adequate bone marrow function, hepatic function, renal function, cardiac function and coagulation function. Main Exclusion Criteria: * Metastatic disease. * Previous Whoops resection. * Ex-ulcerating tumors or tumors infiltrating the skin. * Other invasive malignancy within 5 years, with the exception of adequately treated non melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6 prostate cancer. * Any previous radiotherapy (RT) or systemic therapy for the present tumor. * Previous treatment with maximum cumulative doses (450 mg/m² doxorubicin or equivalent 900 mg/m² epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones. * Concomitant or recent (within 30 days of registration) treatment with any other experimental drug. * Concomitant use of other anti-cancer drugs or RT. * No metal implants in the region of tumor or cardiac implant electronic devices (CIEDs). * Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last 12 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension. * Active and uncontrolled infections, in particular urinary tract infections. * Inflammation of the urinary bladder (interstitial cystitis). * History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration. * Vaccination with live vaccines within 30 days prior to registration. * Known hypersensitivity to trial drug(s) or to any component of the trial drug(s).
References
Publications (0)
Data not yet available
No reference posted for this study.