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New treatment option for Sarcoma,Soft Tissue
Official title Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue Sarcoma (TNT-HYPE)
ClinicalTrials.gov ID: NCT06835049
What this study is testing
What is Doxorubicin?
Doxorubicin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sarcoma,soft tissue.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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%.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- 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...
- Measurable disease per RECIST v1.1.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- Main
- 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...
- 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
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Aarau, Switzerland
- Basel, Switzerland
- Bellinzona, Switzerland
- Bern, Switzerland
- Lausanne, Switzerland
- Sankt Gallen, Switzerland
- Winterthur, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarau, Switzerland; Basel, Switzerland; Bellinzona, Switzerland; Bern, Switzerland; Lausanne, Switzerland; Sankt Gallen, Switzerland and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.