Actively Recruiting
Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
Led by Swiss Cancer Institute · Updated on 2025-12-30
24
Participants Needed
8
Research Sites
283 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary high-risk soft tissue sarcoma of extremity or trunk
- High-risk defined by Sarculator tool with 10-year overall survival probability less than 60%
- Tumor must be resectable based on pre-operative imaging and local sarcoma team assessment
- Measurable disease according to RECIST v1.1 criteria
- Diagnostic biopsy available for central pathology review
- Candidate for chemotherapy and loco-regional hyperthermia according to protocol
- Adequate bone marrow, liver, kidney, heart, and coagulation function
You will not qualify if you...
- Metastatic disease
- Previous Whoops resection
- Tumors that are ex-ulcerating or infiltrating the skin
- Other invasive cancers within 5 years, except treated non-melanoma skin cancer, localized cervical cancer, or localized prostate cancer with Gleason score 6 or less
- Prior radiotherapy or systemic therapy for current tumor
- Previous treatment with maximum cumulative doses of anthracyclines or anthracenediones
- Concomitant or recent (within 30 days) treatment with experimental drugs
- Use of other anti-cancer drugs or radiotherapy during study
- Presence of metal implants near tumor or cardiac implant electronic devices
- Severe or uncontrolled cardiovascular disease including recent myocardial infarction, serious arrhythmias, prolonged QT, or uncontrolled hypertension
- Active uncontrolled infections, especially urinary tract infections
- Interstitial cystitis
- History of stroke or brain hemorrhage within 6 months
- Vaccination with live vaccines within 30 days
- Known allergy to trial drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Kantonsspital Aarau
Aarau, Switzerland, 5001
Actively Recruiting
2
Universitaetsspital Basel
Basel, Switzerland, CH-4031
Actively Recruiting
3
EOC - Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Actively Recruiting
4
Inselspital Bern - Universitätsklinik für Radioonkologie
Bern, Switzerland, 3010
Actively Recruiting
5
CHUV - Swiss Cancer Center Lausanne
Lausanne, Switzerland, 1011
Actively Recruiting
6
hoch Health Ostschweiz - Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007
Actively Recruiting
7
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
8
Universitätsspital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
G
Gwendoline Wicki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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