Sarcoma
Concept
Initial Situation
The data on the value of LT in oligometastatic tumors are insufficient with regard to the level of evidence. So far, only phase II studies exist on this question. In most studies systemic therapies were also part of the therapy before or after the Local therapies were introduced. No prospective data exist for STS patients. LT procedures, such as surgical resection of metastases as well as interventional procedures by radiotherapists and radiologists, as well as isolated limb perfusion (ILP), are part of the repertoire of certified sarcoma centers. Frequently, local therapy is performed in addition to systemic therapy, which can still be combined with regional hyperthermia if the therapeutic approach is curative. Since there are no evidence-based standards for the use of local therapies in oligometastatic patients with STS, the indication is determined situationally in the multidisciplinary tumor board.
Study Objectives
The establishment of evidence-based recommendations for LT with possible consideration of biomarkers would lead to quality improvement in the care of oligometastatic STS patients in Bavaria. Furthermore, the establishment of structures for prospective data and biomaterial collection including imaging data offers extensive opportunities for translational research approaches that sustainably strengthen the science location in Bavaria and are of international visibility. The special and scientifically poorly understood clinical picture of oligometastasis, combined with the LT know-how available at the centers as well as extended molecular and imaging analyses, a considerable gain in knowledge is expected. Since randomised studies on LT do not seem to be very promising due to the rarity of the disease and the expected lack of patient compliance, the aim is to establish a prospective registry including a large number of BZKF infra- and lighthouse structures.
Milestones
Within the funding timeframe of 18 months, retrospective data collection and multiparametric analysis will be performed. The following milestones are planned for this:
Months 1-3: CRF/eCRF preparation, ethics submissions.
Months 4-12: Data collection and entry into CRF/eCRF
Months 13-18: Scientific evaluation, presentation of research results at a scientific
Long-term goals
»Defining the role of local consolidative therapy for patients with oligometastatic soft tissue sarcoma and establishing therapy guidelines
» Collection and storing of tissue samples and imaging
» Retrospective data collection and constant exchange of clinical study activities, so that the study inclusion of patients at centers of the BZKF is additionally promoted
» Conducting clinical trials