Actively Recruiting
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
Led by Swiss Cancer Institute · Updated on 2025-12-30
24
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new combined treatment approach for rare high-risk soft tissue sarcomas (STSs) located in the extremities and trunk. These cancers have a 5-year survival rate of about 60%, and there is currently no standard treatment for this group. Evidence from earlier studies suggests that adding moderate regional hyperthermia (HT) to chemotherapy, followed by surgery and radiotherapy (RT), may improve long-term survival. This trial aims to optimize treatment by combining the best regimens from chemotherapy, HT, RT, and surgery into a total neoadjuvant treatment (TNT) plan and will assess how feasible this approach is for patients. The treatment consists of three neoadjuvant cycles of doxorubicin combined with either ifosfamide or dacarbazine (used only for leiomyosarcoma), alongside hyperthermia sessions. Each chemotherapy cycle lasts three weeks, with HT sessions on days 1 and 3 of each cycle. After chemotherapy and HT, patients receive radiotherapy, ideally starting about 19 days after the last chemotherapy dose, delivered daily except weekends over several weeks. Surgery to remove tumors is planned about six weeks after completing radiotherapy. Overall, the treatment period lasts about 20 weeks. Participants will be closely monitored throughout the trial, including up to 36 months after surgery. Researchers will assess how well patients tolerate the combined treatment schedule as the primary goal. They will also track disease-free survival, measuring the time until tumor relapse, disease progression, or death up to three years after starting the trial. Assessments include imaging, pathology reviews, and evaluations of organ functions to ensure safety and treatment effectiveness.
CONDITIONS
Brief 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 according to the Sarculator tool with 10-year overall survival probability below 60%
- Resectable tumor as defined by local sarcoma team based on pre-operative imaging
- Measurable disease according to RECIST v1.1 criteria
- Available diagnostic biopsy for central pathology review
- Candidate for chemotherapy regimen per protocol
- Candidate for loco-regional hyperthermia
- Adequate bone marrow, liver, kidney, heart, and coagulation function
You will not qualify if you...
- Presence of metastatic disease
- Previous Whoops resection
- Ulcerating tumors or tumors infiltrating the skin
- Other invasive malignancy within 5 years except certain treated skin, cervical, or prostate cancers
- Prior radiotherapy or systemic therapy for the current tumor
- Prior treatment exceeding cumulative anthracycline dose limits
- Recent treatment with other experimental drugs within 30 days
- Concurrent use of other anti-cancer drugs or radiotherapy
- Metal implants near tumor or cardiac implant electronic devices
- Severe or uncontrolled cardiovascular diseases including recent heart attack or serious arrhythmias
- Active uncontrolled infections, especially urinary tract infections
- Inflammation of the urinary bladder
- Recent cerebrovascular accident or intracranial hemorrhage within 6 months
- Vaccination with live vaccines within 30 days
- Known hypersensitivity to trial drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks (3 cycles of 3 weeks each)
Participants receive 3 neoadjuvant cycles of chemotherapy with doxorubicin combined with either ifosfamide or dacarbazine, alongside hyperthermia treatments on days 1 and 3 of each chemotherapy cycle.
Multiple visits for chemotherapy and hyperthermia sessions during each 3-week cycle
Duration - 2 to 5 weeks
Participants receive radiotherapy starting about 19 days after the last chemotherapy dose, administered once daily except on weekends, over a period of 2 to 5 weeks depending on the fractionation schedule used.
Daily visits excluding weekends for radiotherapy sessions
Duration - Surgery day plus immediate recovery period
Standard surgical resection of tumors is performed approximately 6 weeks after completing radiotherapy.
1 surgical procedure with post-operative hospital care
Duration - 36 months
Participants are monitored for disease progression and overall health for up to 36 months after surgery.
Periodic follow-up visits as scheduled by the study team
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
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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