NCT06835049 Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
| NCT ID | NCT06835049 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Swiss Cancer Institute |
| Condition | Sarcoma,Soft Tissue |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2025-10-27 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
Emanuel Stutz, MD
STUDY DIRECTOR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06835049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sarcoma,Soft Tissue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06835049 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06835049 currently recruiting?
Yes, NCT06835049 is actively recruiting participants. Contact the research team at trials@sakk.ch for enrollment information.
Where is the NCT06835049 trial being conducted?
This trial is being conducted at Aarau, Switzerland, Basel, Switzerland, Bellinzona, Switzerland, Bern, Switzerland and 4 additional locations.
Who is sponsoring the NCT06835049 clinical trial?
NCT06835049 is sponsored by Swiss Cancer Institute. The principal investigator is Emanuel Stutz, MD at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 24 participants.