Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)

Launched by SWISS GROUP FOR CLINICAL CANCER RESEARCH · Feb 13, 2025

Keywords

ClinConnect Summary

The clinical trial called TNT-HYPE is exploring a new treatment approach for patients with high-risk soft tissue sarcomas (STSs) located in the arms, legs, or trunk. Soft tissue sarcomas are rare cancers, and patients with high-risk cases currently have limited treatment options. This study aims to see if combining different treatments—chemotherapy, regional heating (called hyperthermia), surgery, and radiation therapy—can improve survival rates. Specifically, it’s looking at whether a total neoadjuvant treatment (TNT) approach, which means giving treatments before surgery, is feasible and effective for these patients.

To participate in this trial, patients must have a confirmed diagnosis of high-risk STS in the extremities or trunk, and their tumor must be operable based on imaging tests. They should also be able to receive the planned chemotherapy and hyperthermia treatments. Participants can expect to undergo various assessments to determine their eligibility and if they can handle the planned treatments. It’s important to note that the trial is not yet recruiting, and certain health conditions and previous treatments may exclude patients from participation. Overall, this study hopes to improve treatment options for patients facing this challenging diagnosis.

Gender

ALL

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).