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

Sponsor
Centre Paul Strauss
Study ID
NCT06476704
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Jun 26, 2024
Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Oct 15, 2028
Completion
Jun 1, 2033

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT) [ Time Frame: At surgery (Between 4 and 8 weeks after the end of radiotherapy) ]

Central Contacts

Related Studies