ANTICIPATE – Understanding the influence of psychosocial factors on treatment side effects and outcomes in patients with soft tissue sarcoma
Recruiting
- Conditions
- C49.0Connective and soft tissue of head, face and neck
- Registration Number
- DRKS00032748
- Lead Sponsor
- Medizinische Klinik und Poliklinik III der LMU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
None
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Toxicity according to CTCAE V.5/6 (assessment during the entire thermochemotherapy, laboratory controls at least once a week in the interval)<br>- Radiologic response to therapy according to RECIST 1.1 (after the 2nd cycle, after the 4th cycle)
- Secondary Outcome Measures
Name Time Method - B-IPQ (start of thermochemotherapy)<br>- GEEE (start of thermochemotherapy, after the 1st cycle, after the 4th cycle and 1st aftercare presentation after completion of therapy)<br>- QLQ-C30 (start of thermochemotherapy, after the 1st cycle, after the 4th cycle and 1st aftercare presentation after completion of therapy)<br>- Pathological response to therapy according to EORTC-STBSG (resection usually after 4 cycles)<br>- Progression-free survival (PFS, follow-up: 2 years)<br>- Overall survival (OS, follow-up: 2 years)