NCT04946357Active, not recruiting
Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 21 Jun 2021
- Start date
- 21 Jun 2021
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University Hospital Heidelberg
- Diseases
- Sarcoma
- NCT number
- NCT04946357
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 21 Jun 2021 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Metal implants that influence treatment planning with ions
- Previous radiotherapy in the treatment area
Other illness
- Active medical implants for which no ion beam irradiation permit exists at the time of treatment (e.g., cardiac pacemaker, defibrillator)
Other
- Stage IV (distant metastases)
- Lymph node metastasis
- Desmoid tumors
- Simultaneous participation in another clinical trial that could influence the results of the study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Heidelberg, Department of RadioOncology Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.