NCT06022159RecruitingPhase 2
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.
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.
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 16 Aug 2023
- Start date
- 28 Nov 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Institut Claudius Regaud
- Diseases
- Sarcoma
- NCT number
- NCT06022159
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 28 Nov 2023 to the primary completion date, Sept 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy in the area.
- Concomitant or sequential chemotherapy.
- Patient requiring total surgery (amputation).
Other illness
- Metastatic disease.
- Other cancer under treatment.
- Any condition or pathology contraindicating MRI.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Institut Regional Du Cancer de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Institut Curie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Institut de Cancérologie de l'Ouest Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| IUCT-O Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.