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Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions

ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Stage IV (distant metastases)

Lymph node metastasis

Metal implants that influence treatment planning with ions

Previous radiotherapy in the treatment area

Trial design

Design model

Parallel

Treatments tested in this trial

  • Protons

    Radiation

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

  • carbon ions

    Radiation

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

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Arm A: Protons, 39 Gy (RBE) in 13 fractions (single dose 3.0 Gy(RBE))Experimental treatment 1 intervention
Group B: Arm B: Carbon ions, 39 Gy(RBE) in 13 fractions (single dose 3.0 Gy(RBE))Experimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

LC: Local control

LC: Local control determined from local onset to local tumor progression

Time frame
from start of radiotherapy to local onset to local tumor progression up to 5 years
2

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

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

Time frame
from start of radiotherapy to onset of therapy of local tumor progression up to 5 years
3

DFS: Disease-free survival

DFS: Disease-free survival determined from onset of therapy until local and / or distant tumor progression

Time frame
from start of radiotherapy to onset of therapy until local and / or distant tumor progression up to 5 years
4

OS: Overall survival

OS: Overall survival until death or censorship

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Heidelberg

Lead sponsor

Source ClinicalTrials.gov
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