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

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

• Evaluation of the acute tolerance o f L-TC [Срок оценки: Up to day 5 (every day during the treatment)]
• Evaluation of the late tolerance o f L-TC [Срок оценки: Up to day 28 after the end of treatment.]
• Evaluation of the acute tolerance of radiotherapy [Срок оценки: Up to day 5 (every day during the treatment)]
• Evaluation of the late tolerance of radiotherapy [Срок оценки: at 4 months after surgery, and at 12, 18, 24, 36 and 60 months]
• Evaluation of tumour necrosis [Срок оценки: At surgery (Between 4 and 8 weeks after the end of radiotherapy)]
• Evaluation of the radiological response [Срок оценки: at screening and before surgery]
• Proportion of patients with R0 resection [Срок оценки: At surgery]
• Evaluation of the Local Progression-Free Survival (L-PFS) [Срок оценки: at 12, 24, 36 and 60 months.]
• Evaluation of the Distant Progression-Free Survival (D-PFS) [Срок оценки: at 12, 24, 36 and 60 months.]
• Evaluation of the Overall Survival (OS) [Срок оценки: at 12, 24, 36 and 60 months]
• Evaluation of the Quality of Life (QoL) [Срок оценки: at the inclusion (baseline) and every 4 months the two first years and then every 6 months the next three years]