Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
Who is this study for? Adult patients with Retroperitoneal Soft Tissue Sarcoma
What treatments are being studied? Carbon Ion Irradiation
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
• Karnofsky index of ≥ 70%
• Age from 18 years
• Completed patient information and written consent
• ability to give consent
Locations
Other Locations
Germany
University Hospital of Heidelberg, Radiation Oncology
RECRUITING
Heidelberg
Contact Information
Primary
Juergen Debus, Prof.
juergen.debus@med.uni-heidelberg.de
+496221
Backup
Katharina Seidensaal, MD
katharina.seidensaal@med.uni-heidelberg.de
+496221
Time Frame
Start Date: 2019-05-09
Estimated Completion Date: 2027-05-09
Participants
Target number of participants: 64
Treatments
Active_comparator: Proton Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
Experimental: Carbon Ion Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment
Related Therapeutic Areas
Sponsors
Leads: University Hospital Heidelberg