Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

NCT04946357 · tracked via the Priya Life Science Germany tracker

Sponsor

University Hospital Heidelberg

Phase

Not applicable

Started

2021-06-21

Last updated

2026-07-08

Condition(s) studied

Soft Tissue Sarcoma

Investigational drug(s) / intervention(s)

Protonscarbon ions

Protons: proton irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions

carbon ions: carbon ion irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Proportion of therapies without wound healing disorders and/or discontinuation — from the beginning of radiotherapy (day1) until a maximum of 120 days after the resection
Proportion of therapies without wound healing disorders and / or discontinuation in each study arm.

Trial sites (1)

Facility	City	Region	Status
University Hospital Heidelberg, Department of RadioOncology	Heidelberg	Baden-Wurttemberg

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04946357 on ClinicalTrials.gov ↗ ← All trials in Germany