Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial.
K Seidensaal, M Kieser, A Hommertgen...
https://pubmed.ncbi.nlm.nih.gov/33579340Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04219202
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospective Randomized Phase II Study
Led by University Hospital Heidelberg · Updated on 2026-03-10
64
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a hypofractionated, accelerated radiation treatment using protons or carbon ions for patients with retroperitoneal soft tissue sarcomas. This study is a randomized, open, prospective phase II trial focused on the incidence of serious (Grade 3-5) toxicities and therapy termination rates during neoadjuvant radiation followed by tumor surgery. The special physical properties of protons and carbon ions may help protect nearby organs such as the intestines, kidneys, and liver during treatment. Participants are randomly assigned to one of two groups: one receiving proton radiation and the other receiving carbon ion radiation. Both groups receive a total dose of 39 Gy delivered in 13 fractions with a standard dose of 3.0 Gy per fraction, six times per week. The treatments use active beam guidance targeting the tumor before surgical removal. During the study, participants will be monitored for adverse events, treatment completion, and secondary outcomes including tumor control, progression-free survival, disease-free survival, overall survival, and quality of life using the EORTC QLQ-C30 questionnaire. The primary outcome is the incidence of serious toxicities within 12 months after radiation treatment, with ongoing assessments of safety and treatment feasibility throughout the study period.
CONDITIONS
Brief Title
Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
- Karnofsky index of 65 70%
- Age from 18 years
- Completed patient information and written consent
- Ability to give consent
You will not qualify if you...
- Stage IV disease with distant metastases
- Presence of lymphogenic metastasis
- Metal implants at the sarcoma site affecting treatment planning
- Previous radiation therapy in the treatment area
- Diagnosis of desmoid tumors, peritoneal sarcomatosis, or gastrointestinal stromal tumors (GIST)
- Participation in another clinical study that might affect results
- Active medical implants without approval for ion irradiation (e.g., pacemaker, defibrillator)
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 2 to 3 weeks
Participants receive neoadjuvant radiation therapy with either proton or carbon ion radiation to treat retroperitoneal soft tissue sarcoma.
13 treatment sessions (in-person) over approximately 2 to 3 weeks
Follow-up
Duration - Up to 12 months after radiation treatment
Participants are monitored for safety, tumor control, progression, survival, and quality of life after completing radiation treatment.
Visits scheduled periodically up to 12 months post-treatment
Trial Site Locations
Total: 1 location
1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120
Actively Recruiting
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Research Team
J
Juergen Debus, Prof.
K
Katharina Kozyra, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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