NCT07507773 Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the Limbs or Trunk Wall
| NCT ID | NCT07507773 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre Oscar Lambret |
| Condition | Soft Tissue Sarcoma Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2032-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 135 participants in total. It began in 2026-07-21 with a primary completion date of 2032-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Abel CORDOBA, MD
PRINCIPAL INVESTIGATOR
Centre Oscar Lambret
Frequently Asked Questions
Who can join the NCT07507773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07507773 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07507773 currently recruiting?
Yes, NCT07507773 is actively recruiting participants. Contact the research team at promotion@o-lambret.fr for enrollment information.
Where is the NCT07507773 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT07507773 clinical trial?
NCT07507773 is sponsored by Centre Oscar Lambret. The principal investigator is Abel CORDOBA, MD at Centre Oscar Lambret. The trial plans to enroll 135 participants.