Tests short radiation before surgery in older adults with soft tissue sarcoma
Tests short-course radiation before surgery in older adults with soft tissue sarcoma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years Old) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
Key facts
- Where
- Bordeaux, Lille, Limoges, Lyon, Montpellier, Paris, Poitiers, Saint-Herblain, Toulouse, and Villejuif, FranceSee the 11 sites
- Phase
- Phase 2
Where in France
- Institut BergonieBordeaux, FranceTaking people
- Centre Oscar LambretLille, FranceTaking people
- CHU de LimogesLimoges, FranceTaking people
- Centre Leon BerardLyon, FranceTaking people
- Institut Regional Du Cancer de MontpellierMontpellier, FranceTaking people
- Institut CurieParis, FranceTaking people
- CHU de PoitiersPoitiers, FranceTaking people
- Institut de Cancérologie de l'OuestSaint-Herblain, FranceTaking people
- CHU de ToulouseToulouse, FranceTaking people
- IUCT-OToulouse, FranceTaking people
- Institut Gustave RoussyVillejuif, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institut Claudius Regaud
- Trial code
- NCT06022159
- Record updated
- 2 June 2026
- Original description
This is a phase II, multicenter, non-randomized study.Read full original descriptionShow less
Phase II Study Evaluating Pre-operative HYPOfractionated Radiation Therapy in Aged (≥ 70 Years) or "Fragile" (≥ 65 Years) Patients With Limb or Trunk Soft Tissue SARComa.
This is a phase II, multicenter, non-randomized study.
The main objective is to evaluate the treatment with hypofractionated radiation therapy in neo-adjuvant situations on wound healing in a population of aged patients (≥ 70 years old) or ≥ 65 years of age defined as "fragile" and treated for soft tissue sarcoma.
A maximum of 48 evaluable patients will be included in this study. The patients will receive an hypofractionated radiation therapy prior to conservative surgery.
Each patient will be followed for up to 3 years after the end of complete treatment (radiotherapy + surgery).
Inclusion: Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk; Indication for neo-adjuvant or adjuvant radiotherapy; Patient aged ≥ 70 years with a performance status ECOG ≤ 2 and/or aged 65 to 70 years with an ECOG of 2 and identified by the investigator as "fragile"; Patient affiliated to a Social Health Insurance in France; Patient able to participate and willing to give informed consent prior performance of any study-related procedures.
Exclusion: Previous radiotherapy in the area; Concomitant or sequential chemotherapy; Patient requiring total surgery (amputation); Metastatic disease; Other cancer under treatment; Any condition or pathology contraindicating MRI; Retroperitoneal, ORL and visceral sarcomas; Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure; Patients included in another therapeutic interventional trial; Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).