Moderately Hypofractionated Neoadjuvant Radiotherapy for Soft Tissue Sarcoma of the Limbs or Trunk Wall

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with localized soft tissue sarcoma of the limbs or trunk wall will receive 15 fractions of 2.7 Gy over 3 weeks (total 40.5 Gy) before surgical removal of the tumor. The study mainly looks at long-term local disease control by tracking progression or recurrence after treatment. Safety and efficacy of the neoadjuvant radiotherapy will be monitored, with follow-ups including MRI, physical exams, and quality-of-life questionnaires. Patients will be followed for up to 5 years after the last participant is enrolled to assess outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Oscar Lambret
  Lille, France Recruiting

Study contacts

• Principal investigator: Abel CORDOBA, MD — Centre Oscar Lambret
• Study coordinator: Julien THERY
• Email: promotion@o-lambret.fr
• Phone: (0)320295918

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.