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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proton Treatment | Active Comparator | Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment |
|
| Carbon Ion Treatment | Experimental | Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton radiation | Radiation | Therapeutic radiation Treatment with Protons |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of grad 3-5 NCI-CTC-AE toxicities | 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 | within 12 month after radiation treatment |
| Measure | Description | Time Frame |
|---|---|---|
| local Tumor control | Number of patients without new arising Tumors at the treated Tumor site | within 12 month after radiation treatment |
| local Progression free survival | Number of patients without local Progression at the treated tumor site |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juergen Debus, Prof. | Contact | +496221 | 8201 | juergen.debus@med.uni-heidelberg.de |
| Katharina Kozyra, Dr | Contact | +496221 | 8201 | katharina.kozyra@med.uni-heidelberg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Heidelberg, Radiation Oncology | Recruiting | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33579340 | Derived | Seidensaal K, Kieser M, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Lehner B, Schneider M, Nienhueser H, Frohling S, Egerer G, Debus J, Uhl M. Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial. Trials. 2021 Feb 12;22(1):134. doi: 10.1186/s13063-021-05069-z. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Carbon Ion radiation |
| Radiation |
Therapeutic radiation Treatment with Carbon Ions |
|
| within 12 month after radiation treatment |
| disease free survival | Number of Patients without relapse of treated disease | within 12 month after radiation treatment |
| Overall survival | Assesment of alive patients | within 12 month after radiation treatment |
| Quality of live | Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6 | within 12 month after radiation treatment |