Administration of L-TC: Administration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session
HFRT alone: HFRT : 30 Gy in 5 fractions of 6 Gy.
1 fraction per day, 5 days per week.
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Evaluation of the efficacy of the L-TC treatment in combination with preoperative hypofractionated radiotherapy (HFRT) — At surgery (Between 4 and 8 weeks after the end of radiotherapy) Pathological complete response rate (pCR): defined as the presence of \< 10% residual malignant viable cells.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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