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

NCT ID: NCT06476704

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2032-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)

L-TC as an IV 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 begin 2 hours before each HFRT fraction. Radiotherapy is scheduled to coincide with the plasma peak, which occurs approximately 2 hours after the start of the infusion. + HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.

Group Type: EXPERIMENTAL

Administration of L-TC

Intervention Type: DRUG

Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session

Hypofractionated radiotherapy alone

HFRT treatment will be administered in control group as 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.

Group Type: ACTIVE_COMPARATOR

HFRT alone

Intervention Type: RADIATION

HFRT : 30 Gy in 5 fractions of 6 Gy.

1 fraction per day, 5 days per week.

Interventions

Administration of L-TC

Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session

Intervention Type: DRUG

HFRT alone

HFRT : 30 Gy in 5 fractions of 6 Gy.

1 fraction per day, 5 days per week.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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)
• R0 surgery is feasible, in reference centers
• Pre-biopsy MRI available
• Performance status of 0-2 and life expectancy of at least 6 months

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEAF4Life, Inc.

INDUSTRY

Sponsor Role: collaborator

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle CHAMBRELANT, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de cancérologie Strasbourg Europe

Georges NOEL, MD, PhD

Role: STUDY_CHAIR

Institut de cancérologie Strasbourg Europe

Locations

CGFL

Dijon, , France

ICANS

Strasbourg, , France

Countries

France

Central Contacts

Manon VOEGELIN

Role: CONTACT

promotion-rc@icans.eu

368339523 ext. +33

Facility Contacts

Gilles TRUC

Role: primary

gtruc@cgfl.fr

33380737518

Georges NOEL

Role: primary

promotion-rc@icans.eu

33368339523

Other Identifiers

2024-515668-30-00

Identifier Type: CTIS

Identifier Source: secondary_id

2020-016

Identifier Type: -

Identifier Source: org_study_id