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PRACTISS: Preoperative Radiotherapy With Liposomal Transcrocetin in Soft Tissue Sarcomas
NCT06476704Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jul 2026
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- Centre Paul Strauss
- Modality
- Small Molecules
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 2, randomised, open-label trial of Liposomal Transcrocetin in soft tissue sarcoma (STS) (2 arms), sponsored by Centre Paul Strauss. Primary endpoint: Pathological Complete Response. Planned start Jul 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Hypofractionated radiotherapy alone
HFRT treatment administered as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)
L-TC as an IV infusion over 90 minutes at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days. HFRT treatment administered as 30 Gy in 5 fractions of 6 Gy.
03
Who it enrols
Adults with localized or locally advanced grade 2/3 soft tissue sarcoma of the extremity planned for preoperative HFRT and surgery, with ECOG PS 0-2 and life expectancy >= 6 months. Excludes specific sarcoma subtypes, prior radiation to the area, and recent other malignancies.
04
Endpoints
Primary
Pathological Complete Response
Secondary
Acute tolerance of L-TC
Late tolerance of L-TC
Acute tolerance of radiotherapy
Late tolerance of radiotherapy
Evaluation of tumour necrosis
Evaluation of the radiological response
Proportion of patients with R0 resection
Local Progression-Free Survival
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