Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital Heidelberg, Department of RadioOncology
RECRUITING
Heidelberg
Contact Information
Primary
Klaus Herfarth, Prof. Dr.
studienkoordination.RAD@med.uni-heidelberg.de
06221 56 34093
Time Frame
Start Date: 2021-06-21
Estimated Completion Date: 2025-07-01
Participants
Target number of participants: 42
Treatments
Experimental: Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Experimental: Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))
Related Therapeutic Areas
Sponsors
Leads: University Hospital Heidelberg

This content was sourced from clinicaltrials.gov