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Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

NCT04946357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-04-06

No results posted yet for this 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.

Conditions

  • Soft Tissue Sarcoma

Interventions

RADIATION

Protons

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

RADIATION

carbon ions

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

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2028-07-01
Completion
2029-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04946357 on ClinicalTrials.gov