C49.0
Conditions
Interventions
Group 1: Patients with soft tissue sarcoma and implementation of multimodal therapy (neoadjuvant/ adjuvant chemotherapy + regional hyperthermia, surgery, if applicable radiotherapy) are asked to compl
Sponsors
Medizinische Klinik und Poliklinik III der LMU München
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Presence of a histologically confirmed soft tissue sarcoma in advanced stage (C.49.0) - Implementation of multimodal therapy starting with a neoadjuvant or adjuvant thermochemotherapy
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Toxicity according to CTCAE V.5/6 (assessment during the entire thermochemotherapy, laboratory controls at least once a week in the interval) - Radiologic response to therapy according to RECIST 1.1 (after the 2nd cycle, after the 4th cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| - B-IPQ (start of thermochemotherapy) - GEEE (start of thermochemotherapy, after the 1st cycle, after the 4th cycle and 1st aftercare presentation after completion of therapy) - QLQ-C30 (start of thermochemotherapy, after the 1st cycle, after the 4th cycle and 1st aftercare presentation after completion of therapy) - Pathological response to therapy according to EORTC-STBSG (resection usually after 4 cycles) - Progression-free survival (PFS, follow-up: 2 years) - Overall survival (OS, follow-up: 2 years) | — |
Countries
Germany
Contacts
Public ContactAnton Burkhard-Meier
Medizinische Klinik und Poliklinik III der LMU München
Outcome results
None listed