Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion (Retro-Ion)
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ClinicalTrials.gov Identifier: NCT04219202 |
Recruitment Status :
Recruiting
First Posted : January 6, 2020
Last Update Posted : June 23, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sarcoma,Soft Tissue | Radiation: Proton radiation Radiation: Carbon Ion radiation | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie |
Actual Study Start Date : | May 9, 2019 |
Estimated Primary Completion Date : | May 9, 2023 |
Estimated Study Completion Date : | May 9, 2024 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Proton Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment
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Radiation: Proton radiation
Therapeutic radiation Treatment with Protons |
Experimental: Carbon Ion Treatment
Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment
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Radiation: Carbon Ion radiation
Therapeutic radiation Treatment with Carbon Ions |
- Incidence of grad 3-5 NCI-CTC-AE toxicities [ Time Frame: 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
- local Tumor control [ Time Frame: within 12 month after radiation treatment ]Number of patients without new arising Tumors at the treated Tumor site
- local Progression free survival [ Time Frame: within 12 month after radiation treatment ]Number of patients without local Progression at the treated tumor site
- disease free survival [ Time Frame: within 12 month after radiation treatment ]Number of Patients without relapse of treated disease
- Overall survival [ Time Frame: within 12 month after radiation treatment ]Assesment of alive patients
- Quality of live [ Time Frame: within 12 month after radiation treatment ]Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219202
Contact: Juergen Debus, Prof. | +496221 ext 8201 | juergen.debus@med.uni-heidelberg.de | |
Contact: Katharina Seidensaal, MD | +496221 ext 8201 | katharina.seidensaal@med.uni-heidelberg.de |
Germany | |
University Hospital of Heidelberg, Radiation Oncology | Recruiting |
Heidelberg, Germany, 69120 | |
Contact: Matthias Uhl, PD +49-6221-56 ext 8202 Matthias.uhl@med.uni-heidelberg.de | |
Contact: Adriane Hommertgen +49-6221-56 ext 8202 adriane.hommertgen@med.uni-heidelberg.de | |
Sub-Investigator: Katharina Seidensaal, MD |
Responsible Party: | Juergen Debus, Princip Investigator, University Hospital Heidelberg |
ClinicalTrials.gov Identifier: | NCT04219202 |
Other Study ID Numbers: |
Rad-ONK Retro-Ion |
First Posted: | January 6, 2020 Key Record Dates |
Last Update Posted: | June 23, 2021 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |