Clinical trial · Interventional
Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized prospective open-label phase 2 trial testes the safety and feasibility of a hypofractionated accelerated neoadjuvant proton or carbon ion radiotherapy based on the rate of wound healing disorders from beginning of radiotherapy to maximum 120 days after the planned tumor resection or discontinuation of treatment due to any reason. The treatment is of shorter duration (2-3 weeks vs. 5 weeks standard treatment), which should please most patients and thus enhance quality of life. The treatment regimen furthermore promises a reduced rate of late side effects and significant optimization of the current treatment standards. A phase II trial is mandatory not only for obtaining the safety and feasibility data, but also in order to prepare a concurrent phase III trial. Due to the low incidence of soft tissue sarcoma, only a well prepared multicenter study has a chance to be successfully completed based on previous experiences in trials for seldom tumor entities.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carbon ions | Radiation | — | UNRESOLVED |
| Protons | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
- description
- Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
- interventionNames
- Radiation: Protons
- type
- EXPERIMENTAL
- label
- Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))
- description
- Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))
- interventionNames
- Radiation: carbon ions
Primary outcomes (1)
- measure
- Proportion of therapies without wound healing disorders and/or discontinuation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed soft-tissue sarcoma of the extremities with an indication for perioperative radiation treatment * Resectable or marginally resectable * Karnofsky index of ≥ 70% * Age ≥ 18 years * Carried out patient education and written consent * Patient is capable to give informed consent Exclusion Criteria: * Stage IV (distant metastases) * Lymph node metastasis * Metal implants that influence treatment planning with ions * Previous radiotherapy in the treatment area * Desmoid tumors * Simultaneous participation in another clinical trial that could influence the results of the study. * Active medical implants for which no ion beam irradiation permit exists at the time of treatment (e.g., cardiac pacemaker, defibrillator)
References
Publications (1)
- DERIVEDBrugemann D, Lehner B, Kieser M, Krisam J, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Sedlaczek O, Egerer G, Geisbusch A, Uhl M, Debus J, Seidensaal K. Neoadjuvant irradiation of extremity soft tissue sarcoma with ions (Extrem-ion): study protocol for a randomized phase II pilot trial. BMC Cancer. 2022 May 12;22(1):538. doi: 10.1186/s12885-022-09560-x. PMID 35550036