Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas

ConditionSarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

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

42 Participants
are divided into 2 treatment groups

Locations

2
CGFL Dijon France
ICANS Strasbourg France

Sponsors and collaborators

Centre Paul Strauss

Lead sponsor

LEAF4Life, Inc.

Collaborator