Soft Tissue Sarcoma Adult
Conditions
Keywords
Soft tissue sarcomas, immunological examinations, neoadjuvant therapy, radiotherapy
Brief summary
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcoma is a prospective study with additional translational research using preoperative and postoperative tissue, blood sampling and advanced imaging.
Detailed description
All patients (\> 18 Years) with histologically confirmed high-risk soft tissue sarcoma eligible for neoadjuvant multimodal therapy (including radiotherapy +/- concomitant and sequential chemotherapy +/- hyperthermia as well as surgery) are screened for the study. Neoadjuvant therapy consists of 50-50.4 Gy in 25-28 fractions. Additional concomitant or sequential chemotherapy may be applied in selected cases (young patients, high-grade tumors). Additional hyperthermia concomitant to neoadjuvant radiotherapy is applied in selected cases if not contraindicated. Preoperative tissue sampling to generate primary tumor cell lines in additional translational research is performed in each patient with a lesion suspect for soft tissue sarcoma and eligible for multimodal therapy. Primary cell lines are analyzed biologically (growth pattern, radioresistance, migration, molecular markers RT-PCR, immunological properties such as immunogenic cell death, lysis by cellular immunotherapies such as CAR-NK cells. Postoperative tumor tissues are additionally analyzed for immune cell mapping using complex immunohistochemistry. Biopsy and resection should include proteome analysis and DNA sequencing (only of the tumor tissue, not normal tissue). Additional immunological monitoring (including cellular immune status, serum marker e.g. cell free DNA, HMGB1) is performed using blood sampling with in total 4 blood controls (25 ml each, before neoadjuvant radiotherapy, during the second and last week of radiotherapy as well as before surgery). In patients treated with concomitant MR-guided hyperthermia, weekly MR-imagine is performed. Follow-up is carried out as part of the oncological controls over 5 years. The overall study is planned over a period of 5 years (interventional part), additional 5 years follow-up period.
Interventions
OTHERBlood and tissue collection for immunological studies, advanced imaging.
Blood and tissue collection for immunological studies under neoadjuvant Therapy of soft tissue sarcomas. Prospective data collection and translational accompanying research on standard therapy. Use of tissue, blood samples and advanced imaging.
OTHERneoadjuvant Therapy
neoadjuvant Therapy
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Open Label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned histological confirmation for especially high-risk soft tissue sarcoma via open Sampling * Indication for neoadjuvant multimodal therapy (radiation and locoregional Hyperthermia, optionally with simultaneous chemotherapy) * Planned resection of a department of the CWS * Age \> 18 years * Ability to consent * Additionally for imaging study: Treatment on the combined MR hyperthermia device
Exclusion criteria
* Age \< 18 years * Poor understanding (language etc.) * Lack of reconnaissance ability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the cellular immune status via flow-cytometrie from collected blood samples | 5 years of recruitment, 5 years follow-up | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. |
| Description of the cellular immune status on tissue samples ussing komplex immunohistochemie | 5 years of recruitment, 5 years follow-up | Tissue samples are taken as incisional biopsie as well as in the tumor tissue after the surgery |
| Measurement of the cellular free DNA from collected blood samples | 5 years of recruitment, 5 years follow-up | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. |
| Measurement of HMGB1 from collected blood samples | 5 years of recruitment, 5 years follow-up | Blood samples are taken on the days of simulation-CT, first and third week of the radiation therapy, as well as before surgery. |
| Evaluation of morphological tumor characteristics (size, diffusion) with weekly MRIs | 5 years of recruitment, 5 years follow-up | Weekly MRIs during neoadjuvant radiation therapy |
Countries
Germany
Contacts
Primary ContactFranziska Eckert, MD, Prof.
Backup ContactVlatko Potkrajcic, MD
Outcome results
None listed