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

NCT06476704 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2020-0162024-515668-30-00
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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).

Conditions

Sarcoma

Keywords

hypofractionated radiotherapy; soft tissue sarcoma; hypoxia; liposomal transcrocetin; neo-adjuvant

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT)

  Pathological complete response rate (pCR): defined as the presence of \< 10% residual malignant viable cells.

  At surgery (Between 4 and 8 weeks after the end of radiotherapy)

Secondary Outcomes (11)

• Evaluation of the acute tolerance o f L-TC

  Up to day 5 (every day during the treatment)

• Evaluation of the late tolerance o f L-TC

  Up to day 28 after the end of treatment.

• Evaluation of the acute tolerance of radiotherapy

  Up to day 5 (every day during the treatment)

• Evaluation of the late tolerance of radiotherapy

  at 4 months after surgery, and at 12, 18, 24, 36 and 60 months

• Evaluation of tumour necrosis

  At surgery (Between 4 and 8 weeks after the end of radiotherapy)

Study Arms (2)

Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)

EXPERIMENTAL

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.

Drug: Administration of L-TC

Hypofractionated radiotherapy alone

ACTIVE COMPARATOR

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.

Radiation: HFRT alone

Interventions

Administration of L-TC DRUG

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

Hypofractionated radiotherapy + Liposomal Transcorcetin (L-TC)

HFRT alone RADIATION

HFRT : 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.

Hypofractionated radiotherapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• LEAF4Life, Inc.: collaborator

Study Sites (2)

CGFL

Dijon, France

Location

ICANS

Strasbourg, France

Location

MeSH Terms

Conditions

Sarcoma; Hypoxia

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isabelle CHAMBRELANT, MD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

• Georges NOEL, MD, PhD

  Institut de cancérologie Strasbourg Europe

  STUDY CHAIR

Central Study Contacts

Manon VOEGELIN

CONTACT

368339523; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): June 1, 2032
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)