CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 64 target
Drug / intervention
Proton radiation +1 moreradiation
Likely dose
Not stated in record
Key inclusion· 4
  • Histologically confirmed retroperitoneal soft-tissue sarcoma
  • Resectable or marginally resectable disease
  • Age 18 years or older
  • Written informed consent
Key exclusion· 8
  • Stage IV (distant metastases)
  • Lymphogenic metastasis
  • Metal implants at sarcoma level affecting treatment planning
  • Previous radiation therapy in treatment area

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04219202
NCT04219202N/ARecruitingMonitorUpdated 3mo ago · Completion was 1mo ago
Slow Enrollment
Long Recruiting
Monitor

Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion Prospektive Randomisierte Phase-II-Studie

University Hospital Heidelberg·interventional·Posted Jan 6, 2020·Updated Mar 10, 2026

In Brief

A clinical study evaluating Proton radiation and Carbon Ion radiation for Sarcoma,Soft Tissue. Currently recruiting, targeting 64 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ARecruiting
20202021202220232024202520262027
First PostedJan 6, 2020
Enrollment StartMay 9, 2019
Primary CompletionMay 9, 2026
Study CompletionMay 9, 2027
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 6.5 years ago

Interventions

Proton radiationradiation

Therapeutic radiation Treatment with Protons

Carbon Ion radiationradiation

Therapeutic radiation Treatment with Carbon Ions