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).
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)
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
Parallel
Administration of L-TC
DrugAdministration of L-TC (300 mg) as an IV perfusion, daily before each radiotion session
HFRT alone
RadiationHFRT : 30 Gy in 5 fractions of 6 Gy. 1 fraction per day, 5 days per week.
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.
Evaluation of the acute tolerance o f L-TC
Toxicities and biological analysis before each injection of L-TC and before surgery, described by type and grade, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 classification
Evaluation of the late tolerance o f L-TC
Toxicities and biological analysis before each injection of L-TC and before surgery, described by type and grade, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 classification
Evaluation of the acute tolerance of radiotherapy
Global tolerance (radiotherapy toxicities (oedema, radiodermatitis, fibrosis, bone fracture) and laboratory abnormalities) at each physician consultation for radiotherapy and at follow-up, using the CTCAE v.5.0 classification
Evaluation of the late tolerance of radiotherapy
Global tolerance (radiotherapy toxicities (oedema, radiodermatitis, fibrosis, bone fracture) and laboratory abnormalities) at each physician consultation for radiotherapy and at follow-up, using the CTCAE v.5.0 classification
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Centre Paul Strauss
Lead sponsor
LEAF4Life, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
