NCT06476704

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

Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin (L-TC) in Soft tISsue Sarcomas

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Institut de cancérologie Strasbourg Europe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a non-comparative phase II trial (comparison is made regarding a reference, not 2 between 2 proportions). Considering the wide confidence interval retrieved in literature regarding pCR value with HFRT, pCR value used in the sample size calculation and taken from the literature must be included in the 95% CI of the pCR from the control group. The PRACTISS trial aims to improve treatment outcomes for patients with extremity STS by incorporating Liposomal Transcrocetin (L-TC) with Hypofractionated Radiotherapy (HFRT). L-TC is designed to enhance tumor oxygenation, addressing hypoxia-a significant factor contributing to radioresistance. By reoxygenating tumor cells, L-TC may improve radiosensitivity, increasing the efficacy of radiotherapy and leading to higher rates of pathological complete response (pCR) before surgery. Achieving a higher pCR is associated with better long-term outcomes and reduced recurrence rates. Additionally, the use of HFRT reduces the overall treatment schedule compared to conventional radiotherapy, minimizing the treatment burden for patients and potentially improving their quality of life while maintaining treatment effectiveness. L-TC 300 mg QD, administered as intravenous infusion over 90 minutes, at a fixed dose of 300 mg daily before each HFRT fraction, for a total of 5 days corresponding to the planned five daily HFRT fractions. The intravenous infusion should start 120 minutes before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Administration of L-TC	Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session
RADIATION	HFRT alone	HFRT : 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-10-15
• Completion: 2032-06-01
• First posted: 2024-06-26
• Last updated: 2025-02-04

Locations

2 sites across 1 country: France

Regulatory

• FDA-regulated drug study