Sarcoma,Soft Tissue
Conditions
Brief 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.
Detailed description
With retroperitoneal sarcomas, the patient benefits from neoadjuvant radiotherapy. Due to the special physical properties of particles (protons and C12 carbon ions), in particular the steep lateral dose drop, an improved protection of adjacent risk organs is e.g. Intestine, kidneys, liver etc. during the process of applying radiotherapy is possible. 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.
Interventions
RADIATIONProton radiation
Therapeutic radiation Treatment with Protons
RADIATIONCarbon Ion radiation
Therapeutic radiation Treatment with Carbon Ions
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Stage IV (distant metastases) * Lymphogenic metastasis * Metal implants at the level of the sarcoma, which influence the treatment planning * Previous radiation therapy in the treatment area * Desmoid tumors, peritoneal sarcomatosis, GIST * Simultaneous participation in another clinical study that could influence the results of the respective study * Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator) * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grad 3-5 NCI-CTC-AE toxicities | within 12 month after radiation treatment | Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local Tumor control | within 12 month after radiation treatment | Number of patients without new arising Tumors at the treated Tumor site |
| local Progression free survival | within 12 month after radiation treatment | Number of patients without local Progression at the treated tumor site |
| disease free survival | within 12 month after radiation treatment | Number of Patients without relapse of treated disease |
| Overall survival | within 12 month after radiation treatment | Assesment of alive patients |
| Quality of live | within 12 month after radiation treatment | Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6 |
Countries
Germany
Contacts
CONTACTJuergen Debus, Prof.
CONTACTKatharina Kozyra, Dr
Outcome results
None listed