(P 436) SAKK 57/24 FEASIBILITY OF TOTAL NEOADJUVANT TREATMENT WITH HYPERTHERMIA IN PATIENTS WITH HIGH-RISK EXTREMITY AND TRUNK SOFT TISSUE SARCOMA. A MULTICENTER, SINGLE ARM, OPEN LABEL, PHASE II TRIAL

Author(s)

Attila Kollár, MD (he/him/his)

Consultant
Department of Medical Oncology, University Hospital Bern, Inselspital
Bern, Bern, Switzerland

Co-Author(s)

Lars H. H. Lindner, MD (he/him/his)

Head Sarcoma Medical Oncology
Department of Medicine III, LMU University Hospital, Munich, Germany
Munich, Bayern, Germany
DD

Daniel Dietrich, n/a

Swiss Group of Clinical Cancer Research
Bern, Bern, Switzerland
OR

Oliver Riesterer, MD

Center of Radiation Oncology, Cantonal Hospital Aarau
Aarau, Aargau, Switzerland
TZ

Thomas Zilli, MD

Department of Radiation Oncology, Institute of Southern Switzerland
Bellinzona, Ticino, Switzerland
FK

Fatime Krasniqi, MD

Department of Oncology, University Hospital Basel
Basel, Basel-Stadt, Switzerland
LB

Lorenz Bankel, MD

Department of Medical Oncology and Hematology, University Hospital Zurich
Zürich, Zurich, Switzerland
CA

Christina Appenzeller, MD

Department of Medical Oncology and Hematology, Cantonal Hospital St. Gallen
Sankt Gallen, Sankt Gallen, Switzerland
Ralph Zachariah, MD

Senior Consultant
Department of Medical Oncology and Hematology, Kantonsspital Winterthur
Winterthur, Zurich, Switzerland
ES

Emanuel Stutz, MD

Consultant
Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland

Objective: Despite optimal local treatment, 40-50% of patients affected by localized high-risk extremity and trunk soft tissue sarcoma (eSTS) die of metastatic disease. Two recent phase III randomized trials including neoadjuvant anthracyclin-based combination chemotherapy followed by surgery and radiotherapy showed an impressive survival outcome, which now has evolved as a potential new standard of care in high-risk eSTS. Based on the results of another phase III randomized EORTC trial the combination of hyperthermia with perioperative chemotherapy in STS might increase overall survival. Consequently, we are aiming at combining hyperthermia with neoadjuvant chemotherapy followed by radiotherapy and surgery in a total neoadjuvant treatment (TNT) setting. If feasibility is proven and the study were to demonstrate promising efficacy data, the results could serve as the basis for conducting an international randomised study.

Objective: Primary: To assess protocol feasibility when hyperthermia is added concomitantly to standard of care neoadjuvant chemotherapy. Secondary: To assess the safety and efficacy in terms of 3-years disease-free survival, 3-years overall survival and radiological/pathologic response rate.

Methods: In this national, multicenter, prospective, interventional, single-arm phase II trial (NCT06835049) conducted by 7 Swiss sarcoma centers and supported by SAKK (Swiss Group for Clinical Cancer Research) all patients suffering from localized, high-risk eSTS according to the prognostic Sarculator tool (10-year OS probability < 60%) will receive three cycles of neoadjuvant chemotherapy followed by radiotherapy and surgery. Chemotherapeutic treatment will consist of Doxorubicin/Ifosfamide in non-leiomyosarcoma-STS and Doxorubicin/Dacarbacine in leiomyosarcoma, respectively. As this new TNT approach has not yet been prospectively evaluated, feasibility is defined as primary endpoint, defined as percentage of patients who complete treatment according to protocol. 24 patients will be enrolled. The protocol feasibility rate will be estimated with a two-sided 90% Clopper-Pearson confidence interval. All time-to-event endpoints will be analyzed by the Kaplan-Meier method. Additionally, QoL will be assessed by the EORTC QLQ-C30. A central pathology and imaging review will be performed.

Results: N/A This abstract is submitted under Trials in Progress

Conclusion: N/A This abstract is submitted under Trials in Progress