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

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

NCT ID: NCT06476704

Condition: Sarcoma

Conditions: Official terms:
Sarcoma

Conditions: Keywords:
hypofractionated radiotherapy
soft tissue sarcoma
hypoxia
liposomal transcrocetin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Administration of L-TC
Description: Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session
Arm group label: Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)

Intervention type: Radiation
Intervention name: HFRT alone
Description: HFRT : 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
Arm group label: Hypofractionated radiotherapy alone

Summary: This is phase II randomized, multicenter study of treatment with liposomal trasncrocetin (L-TC) and preoperative hypofractionated radiotherapy in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity.

Detailed description: Eligible patients will be randomly assigned 2:1 to receive a preoperative hypofractionated radiotherapy alone (Arm A) or L-TC with preoperative hypofractionated radiotherapy (HFRT) (Arm B). All eligible patients will be administered L-TC at a dose of 300 mg as an IV perfusion, daily and the radiation session will be between 30 min and 1h30 after the end of the perfusion. The experimental treatment, L-TC, is a liposomal formulation of trans crocetin developed by LEAF4Life, Inc. Control group will receive HFRT alone.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age ≥ 18 years - Localised or locally advanced soft tissue sarcoma of extremity proven by biopsy whatever its histological grade. - Pathological expert proof-reading in reference centre - Candidate to radiotherapy + surgery as decided in a multidisciplinary tumour board, in reference centre (European Society for Medical Oncology (ESMO) guideline 2021) - R0 surgery is feasible, in reference centres. - Pre-biopsy MRI available - Performance status of 0-2 and life expectancy of at least 6 months - Patients should have normal liver function as defined by ALT, AST and alkaline phosphate less than 3 ULN for the institution. - Patient must have platelet count above >100,000 cells/mm3, hemoglobin > 8 g/dL and an absolute neutrophil count (ANC) of > 1000 cells/mm3. - Patients should have normal renal function as defined by creatinine clearance of 50 ml/min or higher. - Signed informed consent from the patient must be obtained prior to any procedures Exclusion Criteria: - Woman who is pregnant or breastfeeding - Soft tissue sarcoma developed in irradiated area. - Patients with myxoid liposarcoma, embryonal or alveolar rhabdomyosarcoma, Ewing sarcoma, osteosarcoma, angiosarcoma, primitive neuroectodermal tumor, desmoid-type fibromatosis, or dermatofibrosarcoma protuberans - Patient with metastatic disease, other concomitant cancer or history of cancer treated and controlled within the previous 3 years. - Patient who has a known hypersensitivity to crocetins, L-TC or any of its excipients - Patient who cannot or understand French language - Patient under legal protection (curatorship, guardianship) - Patient without French National Health insurance

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institut de cancérologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Contact:
Last name: Manon VOEGELIN

Phone: 368339523

Phone ext: +33
Email: promotion-rc@icans.eu

Start date: January 1, 2025

Completion date: December 31, 2030

Lead sponsor:
Agency: Institut de cancérologie Strasbourg Europe
Agency class: Other

Collaborator:
Agency: LEAF4Life, Inc.
Agency class: Industry

Source: Institut de cancérologie Strasbourg Europe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06476704