Total pre-surgery chemotherapy plus regional hyperthermia for high-risk limb and trunk soft tissue sarcoma (TNT-HYPE)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial combines three neoadjuvant cycles of doxorubicin with either ifosfamide (or dacarbazine for leiomyosarcoma) together with regional moderate hyperthermia, followed by radiotherapy and surgery. Each chemotherapy cycle lasts three weeks and the full neoadjuvant program takes about 20 weeks, with surgical resection afterward and 36 months of follow-up. The primary goal is to test feasibility of delivering this total neoadjuvant treatment (TNT), including the practicalities of providing hyperthermia which may require travel to specialized centers. The protocol targets patients with resectable, measurable high-risk extremity or trunk soft tissue sarcoma and requires adequate organ function and no metastatic disease.

Why it matters

Who can join: the full rules

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).

Where it's running

• Kantonsspital Aarau
  Aarau, Switzerland Recruiting
• Universitaetsspital Basel
  Basel, Switzerland Recruiting
• EOC - Istituto Oncologico della Svizzera Italiana
  Bellinzona, Switzerland Recruiting
• Inselspital Bern - Universitätsklinik für Radioonkologie
  Bern, Switzerland Recruiting
• CHUV - Swiss Cancer Center Lausanne
  Lausanne, Switzerland Recruiting
• hoch Health Ostschweiz - Kantonsspital St. Gallen
  Sankt Gallen, Switzerland Recruiting

Study contacts

• Study coordinator: Gwendoline Wicki
• Email: trials@sakk.ch
• Phone: +41 31 389 91 91

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.