NCT06022159 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.
| NCT ID | NCT06022159 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institut Claudius Regaud |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2026-09 |
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 48 participants in total. It began in 2023-11-28 with a primary completion date of 2026-09.
⚠ 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 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).
Eligibility Criteria
Inclusion Criteria: 1. Patient with histologically confirmed soft tissue sarcoma of the limbs or trunk. 2. Indication for neo-adjuvant or adjuvant radiotherapy. 3. 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". 4. Patient affiliated to a Social Health Insurance in France. 5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures. Exclusion Criteria: 1. Retroperitoneal, ORL and visceral sarcomas. 2. Previous radiotherapy in the area. 3. Metastatic disease. 4. Concomitant or sequential chemotherapy. 5. Patient requiring total surgery (amputation). 6. Other cancer under treatment. 7. Any condition or pathology contraindicating MRI. 8. Any psychological, familial, geographic or social situation, potentially preventing the provision of informed consent or compliance to study procedure. 9. Patients included in another therapeutic interventional trial. 10. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06022159 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Soft Tissue Sarcoma. 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 NCT06022159 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 NCT06022159 currently recruiting?
Yes, NCT06022159 is actively recruiting participants. Contact the research team at AttalKhalifa.Justine@iuct-oncopole.fr for enrollment information.
Where is the NCT06022159 trial being conducted?
This trial is being conducted at Bordeaux, France, Lille, France, Limoges, France, Lyon, France and 7 additional locations.
Who is sponsoring the NCT06022159 clinical trial?
NCT06022159 is sponsored by Institut Claudius Regaud. The trial plans to enroll 48 participants.