Neoadjuvant irradiation for soft tissue sarcoma using ion therapy
Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions
This study is testing a new type of radiation therapy for patients with soft tissue sarcoma in their arms or legs to see if it can shorten treatment time and improve healing while causing fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg, Baden-Wurttemberg) |
| Trial ID | NCT04946357 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of hypofractionated accelerated proton or carbon ion radiotherapy as a neoadjuvant treatment for patients with extremity soft tissue sarcoma. The study aims to reduce treatment duration from the standard 5 weeks to 2-3 weeks, potentially improving patient quality of life while minimizing late side effects. By comparing the rate of wound healing disorders from the start of radiotherapy to 120 days post-surgery, the trial seeks to optimize current treatment standards and prepare for a future phase III trial. The use of particle therapy is expected to enhance dose distribution and spare surrounding healthy tissues.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed soft tissue sarcoma of the extremities that is resectable or marginally resectable.
Not a fit: Patients with stage IV disease, lymph node metastasis, or those who have had previous radiotherapy in the treatment area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes and quality of life for patients with soft tissue sarcoma.
How similar studies have performed: While there have been studies on neoadjuvant radiotherapy, the specific use of proton and carbon ion therapy in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Heidelberg, Baden-Wurttemberg
- University Hospital Heidelberg, Department of RadioOncology — Heidelberg, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Study coordinator: Klaus Herfarth, Prof. Dr.
- Email: studienkoordination.RAD@med.uni-heidelberg.de
- Phone: 06221 56 34093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.