This trial aims to assess the long-term efficacy of moderately hypofractionated neoadjuvant radiotherapy for soft tissue sarcoma in the limbs or trunk wall. The primary outcome is local disease control, assessed by the cumulative incidence of progression/recurrence.
After informed consent has been obtained and eligibility criteria have been checked, a baseline assessment will be performed followed by the experimental treatment: intensity-modulated radiotherapy with a moderately hypofractionated regimen consisting in 15 fractions of 2.7 Gy administered over 3 weeks.
a follow-up assessment will be performed 3 to 4 weeks after the last radiotherapy session.
Tumor resection will be performed 4 to 8 weeks after the radiotherapy. Patients will then be followed up until the end of the study; planned 5 years after the last inclusion.
Radiotherapy will be evaluated in terms of safety and efficacy.
Patient aged ≥ 18 years ;
Localised sarcoma of a limb, the root of a limb, or the trunk wall ;
Histologically confirmed diagnosis of soft tissue sarcoma regardless of the grade ;
Diagnosis biopsy performed at Centre Oscar Lambret, with specimen available for translational research ;
Metastatic disease (including local lymph node diffusion) ;
Visceral or retroperitoneal sarcoma ;
Tumor considered inoperable even after radiotherapy, according to the multidisciplinary consultation meeting ;
Indication of neoadjuvant or adjuvant chemotherapy ;
Single group
Moderately hypofractionated neoadjuvant radiotherapy
RadiationIntensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks.
Local control of the disease at the two-year follow-up
Local control of the disease will be assessed by cumulative incidence of local progression / recurrence. The main primary outcome analysis will focus on this incidence at the two-year follow-up. The cumulative incidence of local progression / recurrence will be estimated by considering the time between the start of radiotherapy and the date of local progression / recurrence. For patients who are free of local progression / recurrence, this time will be censored at the last follow-up. Death without prior local progression / recurrence and metastatic progression / recurrence without prior local progression / recurrence will be considered competing events. Pre-operative tumor assessment will be performed according to the RECIST 1.1 criteria. For the main analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will not be considered as an event if the patient remains eligible for surgical resection.
Control of the disease at the two-year follow-up
Recurrence-free survival will be defined as the time between the start of radiotherapy and the date of progression / recurrence (local or metastatic) or death, whatever the cause. Observations of patients who were alive and free of progression / recurrence at the last follow up will be censored at that date. The three components of recurrence-free survival will be described: cumulative incidence of local progression / recurrence as described in the primary outcome, cumulative incidence of metastatic recurrence (time between the start of radiotherapy and the date of metastatic progression / recurrence), and cumulative incidence of death without prior progression / recurrence (time between the start of radiotherapy and the date of death without prior progression / recurrence).
Local control of the disease at the two-year follow-up - sensitivity analysis
Local control of the disease will be assessed as described in the main primary outcome but: * For the first sensitivity analysis, metastatic progression / recurrence prior to local progression will not be considered a competing event. * For the second sensitivity analysis, a progressive disease according to RECIST 1.1 criteria during or at the end of radiotherapy will be considered as an event even if the patient remains eligible for surgical resection.
Overall survival
Overall survival will be defined as the time between the start of radiotherapy and the date of death, regardless of the cause. Patients who are alive at the last study follow-up will be consored at that date.
Incidence of amputation
The incidence of amputation will be defined as the time between the start of radiotherapy and the date of amputation regardless of the cause (progressive disease/recurrence, severe trophic complications, ...). Patients who were alive and free of amputation at the last follow-up will be censored at that date. Death without prior amputation will be considered as a competing event. Local or metastatic progression/recurrence will not be considered as a competing event.
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Centre Oscar Lambret
Lead sponsor
Canther, Lille
Collaborator
Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France
Collaborator
