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

NCT06476704 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • LEAF4Life, Inc.

    collaborator INDUSTRY

  • Institut de cancérologie Strasbourg Europe

    lead OTHER

Principal Investigators

  • Isabelle CHAMBRELANT, MD · Institut de cancérologie Strasbourg Europe

  • Georges NOEL, MD, PhD · Institut de cancérologie Strasbourg Europe

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-10-15
Completion
2032-06-01
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476704 on ClinicalTrials.gov