Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
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- STATUS
- Recruiting
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- participants needed
- 64
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- sponsor
- University Hospital Heidelberg
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
Description
With retroperitoneal
The primary study objective is to demonstrate the safety and conduct of study treatment and the incidence of Grade 3-5 NCI-CTC-AE toxicity and / or termination of preferred therapy for any reason. Further target parameter is the proportion of applied therapies without the occurance of degree 3-5 NCI-CTC-AE(s).
The patients are randomized 1: 1 into the two arms (carbon ions vs. protons). Patients receive 39 Gy in (SD 3.0 Gy) in 6 fractions per week.
Secondary study objectives are local control (LC), local progression-free survival from the start of therapy (LPFS), disease-free survival (DFS), overall survival (OS) and quality of life (QoL) determined according to the EORTC-Quality of Life Questionaire (QLQ)- C30 questionnaire.
Details
| Condition |
|
|---|---|
| Age | 18years - 100years |
| Treatment | Proton radiation, Carbon Ion radiation |
| Clinical Study Identifier | NCT04219202 |
| Sponsor | University Hospital Heidelberg |
| Last Modified on | 19 February 2024 |
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