Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall

The NEORASARC clinical trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall.

After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed 8 weeks prior to the start of experimental treatment. This baseline assessment will consist in of a clinical examination, an MRI scan, and the completion of the MSTS and QLQ-C30 questionnaires. After a blood sample has been taken for translational research, the patient will receive the experimental treatment : intensity-modulated radiotherapy delivered in a moderately hypofractionated scheme consisting in 15 fractions of 2.7 Gy over 3 weeks. The total prescribed dose will be 40.5 Gy.

3 to 4 weeks after the last radiotherapy session, patients will undergo an MRI scan.

Tumor resection will be performed 4 to 8 weeks after the radiotherapy. A blood sample will be taken prior to this surgery for translational research.

Patients will then be followed up every 4 months for the first 2 years, every 6 months for 3 years and then annually until the end of the study. At each follow up, a clinical examination, an MRI scan and the completion of the MSTS and QLQ-C30/F17 questionnaires will be performed.

The study is planned to end 5 years after the last inclusion. The security and efficacy of the experimental treatment will be assessed. The main analysis will focus on the cumulative incidence of local progressive disease or recurrence at the two-year follow-up.

It is expected that 90% of patients are free of local progression or recurrence at two years in this population and with different radiotherapy regimen. A proportion of patients free from local progression or recurrence at two years of 90% or less will be considered insufficient (p0 = 90%). The alternative hypothesis under consideration is p1 = 95%.

• Control of the disease at the two-year follow-up [Срок оценки: From enrollment to the end of study, planned 5 years after the last enrollment]
• Local control of the disease at the two-year follow-up - sensitivity analysis [Срок оценки: From enrollment to the two-year follow-up]
• Overall survival [Срок оценки: From enrollment to the end of study, planned 5 years after the last enrollment]
• Incidence of amputation [Срок оценки: From enrollment to the end of study, planned 5 years after the last enrollment]
• Radiological response [Срок оценки: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.]
• Tumor necrosis [Срок оценки: From enrollment to the post radiotherapy MRI planned 3 to 4 weeks after the end of radiotherapy.]
• Histological response [Срок оценки: From enrollment to the surgery planned 6 +/- 2 weeks after the end of radiotherapy.]
• Quality of tumor resection [Срок оценки: From enrollment to surgery planned 6 +/- 2 weekds after the end of the radiotherapy]
• Morbidity [Срок оценки: From enrollment to the end of study, planned 5 years after the last enrollment]
• Limb function [Срок оценки: From enrollment to the 5 years follow-up]
• Quality of life with EORTC QLQ-C30 questionnaires [Срок оценки: From enrollment to the 4 months follow-up]
• Quality of life with EORTC QLQ-F17 questionnaires [Срок оценки: From the first follow-up to the 5 years follow-up]