Moderately hypofractionated neoadjuvant radiotherapy: Intensity-modulated radiotherapy with a moderately hypofractionated scheme consisting of 15 fractions of 2.7 Gy administered over 3 weeks.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 ;
* Indication of neoadjuvant radiotherapy according to the multidisciplinary consultation meeting ;
* Tumor considered operable with a curative intent and conservative intent according to the multidisciplinary consultation meeting ;
* Affiliation to the French National Social Security System ;
* Informed and signed consent
Exclusion Criteria:
* 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 ;
* Ewing tumor of soft tissue, desmoid tumor, embryonal or alveolar rhabdomyosarcoma ;
* Pregnant or breastfeeding women ;
* Patients under protective measures ;
* Patient refusal.
Primary outcome measure(s)
Local control of the disease at the two-year follow-up — From enrollment to 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.
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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