Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

NCT04946357 | Recruiting

• 1 other identifier: EXTREM ION
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of therapies without wound healing disorders and/or discontinuation

  Proportion of therapies without wound healing disorders and / or discontinuation in each study arm.

  from the beginning of radiotherapy (day1) until a maximum of 120 days after the resection

Secondary Outcomes (4)

• LC: Local control

  from start of radiotherapy to local onset to local tumor progression up to 5 years

• LPFS: locally progression-free survival determined from onset of therapy to local tumor progression

  from start of radiotherapy to onset of therapy of local tumor progression up to 5 years

• DFS: Disease-free survival

  from start of radiotherapy to onset of therapy until local and / or distant tumor progression up to 5 years

• OS: Overall survival

  from start of radiotherapy until death or censorship up to 5 years

Study Arms (2)

Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))

EXPERIMENTAL

Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))

Radiation: Protons

Arm B: Carbon ions, 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))

Radiation: carbon ions

Interventions

Protons RADIATION

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

Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))

carbon ions RADIATION

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

Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital Heidelberg, Department of RadioOncology

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• Brugemann D, Lehner B, Kieser M, Krisam J, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Sedlaczek O, Egerer G, Geisbusch A, Uhl M, Debus J, Seidensaal K. Neoadjuvant irradiation of extremity soft tissue sarcoma with ions (Extrem-ion): study protocol for a randomized phase II pilot trial. BMC Cancer. 2022 May 12;22(1):538. doi: 10.1186/s12885-022-09560-x.

  PMID: 35550036 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Protons

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Central Study Contacts

Klaus Herfarth, Prof. Dr.

CONTACT

06221 56 34093; studienkoordination.RAD@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr.

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 30, 2021
• Study Start: June 21, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)