About this trial
This is phase II randomized, multicenter study of treatment with L-TC and preoperative HFRT in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity.
Eligible patients will be randomly assigned 2:1 to receive a preoperative HFRT alone (Arm A) or L-TC with preoperative HFRT (Arm B).
Eligibility criteria
Qualifiers
Age ≥ 18 years
Localized or locally advanced soft tissue sarcoma of extremity proven by biopsy histological grade 2 and 3.
Pathological expert proof-reading in reference centers
HFRT and surgery planned (regardless the potential inclusion in this trial) as decided in a multidisciplinary tumor board, in reference centre (European Society for Medical Oncology (ESMO) guideline 2021)
Disqualifiers
Patient who cannot undergo MRI
Patients with localized or locally advanced soft tissue sarcoma of extremity proven by biopsy with histological grade 1
Previous radiation in the area
Woman who is pregnant or breastfeeding
Trial design
Treatments tested in this trial
- Administration of L-TC
- HFRT alone
Treatment groups
Sponsors and collaborators
Centre Paul Strauss
Lead sponsor
LEAF4Life, Inc.
Collaborator