Neoadjuvant radiation therapy for retroperitoneal soft tissue sarcoma using protons or carbon ions
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie
NA · University Hospital Heidelberg · NCT04219202
This study is testing whether using proton or carbon ion radiation therapy before surgery can safely help patients with retroperitoneal soft tissue sarcomas.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT04219202 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of a hypofractionated, accelerated radiation approach for patients with retroperitoneal soft tissue sarcomas. Participants will be randomly assigned to receive either proton or carbon ion radiation therapy before surgical resection of their tumors. The primary focus is on monitoring the incidence of severe adverse effects and the overall safety of the treatment. Secondary objectives include assessing local control, progression-free survival, disease-free survival, overall survival, and quality of life post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, resectable or marginally resectable retroperitoneal soft tissue sarcomas.
Not a fit: Patients with distant metastases, previous radiation in the treatment area, or specific types of tumors like desmoid tumors or GIST may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and reduce side effects for patients with retroperitoneal soft tissue sarcomas.
How similar studies have performed: While the use of protons and carbon ions in radiation therapy is gaining interest, this specific approach for retroperitoneal sarcomas is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Juergen Debus, Prof.
- Email: juergen.debus@med.uni-heidelberg.de
- Phone: +496221
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.
Conditions: Sarcoma,Soft Tissue