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.

Launched by INSTITUT CLAUDIUS REGAUD · Aug 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation therapy called hypofractionated radiation therapy to see how it affects wound healing in older patients with soft tissue sarcoma, which is a type of cancer found in the body's soft tissues like muscles and fat. The trial includes patients who are at least 70 years old or between 65 and 70 years old and considered "fragile," meaning they may have other health issues that make them more vulnerable. There are two groups in the study: one group will receive radiation therapy before surgery (neo-adjuvant) and the other will have surgery first followed by radiation therapy (adjuvant).

To participate, patients need to have a confirmed diagnosis of soft tissue sarcoma and meet certain health criteria. The researchers will follow each participant for up to three years after their treatment to monitor their progress. It’s important for potential participants to know that they will be supported throughout the study and that their well-being is a priority. The trial is currently recruiting patients, and anyone interested should discuss it with their doctor to see if they qualify.

Gender

ALL

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).