Sarcoma,Soft TissueRetro-IonNCT04219202
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
A study testing Proton radiation and Carbon Ion radiation in people with Sarcoma,Soft Tissue, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue
- What is being tested?
- Proton radiation and Carbon Ion radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- 9 May 2019to 9 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Matthias Uhl, PD, +49-6221-56 ext. 8202, Matthias.uhl@med.uni-heidelberg.de
Adriane Hommertgen, +49-6221-56 ext. 8202, adriane.hommertgen@med.uni-heidelberg.de
About this study
Official title: Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
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.
Read the 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.
- Conditions
- Sarcoma,Soft Tissue
- Being tested
- Proton radiation, Carbon Ion radiation
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton radiationRadiation
Therapeutic radiation Treatment with Protons
Carbon Ion radiationRadiation
Therapeutic radiation Treatment with Carbon Ions
| Study group | Role | What they receive |
|---|---|---|
| Proton Treatment | Active comparator | Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment Receives: Radiation: Proton radiation |
| Carbon Ion Treatment | Experimental | Patient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment Receives: Radiation: Carbon Ion radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 12 month after radiation treatment
Secondary outcomes (5)
local Tumor control
Number of patients without new arising Tumors at the treated Tumor site
Measured: within 12 month after radiation treatment
local Progression free survival
Number of patients without local Progression at the treated tumor site
Measured: within 12 month after radiation treatment
disease free survival
Number of Patients without relapse of treated disease
Measured: within 12 month after radiation treatment
Overall survival
Assesment of alive patients
Measured: within 12 month after radiation treatment
Quality of live
Assessed by EORTC QLQ-C30, Minimum value 0; Maximum value 6
Measured: within 12 month after radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start9 May 2019
- Primary completion9 May 2026 (estimated)
- Study completion9 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma,Soft TissueStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219202
- Sponsor's protocol ID
- Rad-ONK Retro-Ion
- Acronym
- Retro-Ion
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33579340
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
- ClinicalTrials.gov ID
- NCT04219202
- Acronym / sponsor ID
- Retro-Ion / Rad-ONK Retro-Ion
- Conditions
- Sarcoma,Soft Tissue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 9 May 2019 (actual)
- Primary completion
- 9 May 2026 (estimated)
- Study completion
- 9 May 2027 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proton Treatment | Active comparator | Radiation: Proton radiationPatient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Proton Treatment |
| Carbon Ion Treatment | Experimental | Radiation: Carbon Ion radiationPatient receive 39 Gy (in 13 fractions (SD 3,0 Gy) Carbon Ion Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton radiationTherapeutic radiation Treatment with Protons | Radiation | Proton Treatment |
| Carbon Ion radiationTherapeutic radiation Treatment with Carbon Ions | Radiation | Carbon Ion Treatment |
Primary outcome
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
5 secondary outcomes
local Tumor control
Time frame: within 12 month after radiation treatment
local Progression free survival
Time frame: within 12 month after radiation treatment
disease free survival
Time frame: within 12 month after radiation treatment
Overall survival
Time frame: within 12 month after radiation treatment
Quality of live
Time frame: within 12 month after radiation treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 33579340Seidensaal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proton radiation and Carbon Ion radiation in people with Sarcoma,Soft Tissue, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juergen Debus, Prof. (+496221 ext. 8201, juergen.debus@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grad 3-5 NCI-CTC-AE toxicities (time frame: within 12 month after radiation treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04219202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.