Status:
RECRUITING
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.
Lead Sponsor:
Institut Claudius Regaud
Conditions:
Soft Tissue Sarcoma
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 populat...
Eligibility Criteria
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
- Retroperitoneal, ORL and visceral sarcomas.
- Previous radiotherapy in the area.
- Metastatic disease.
- Concomitant or sequential chemotherapy.
- Patient requiring total surgery (amputation).
- Other cancer under treatment.
- Any condition or pathology contraindicating MRI.
- 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).
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06022159
Start Date
November 28 2023
End Date
May 1 2029
Last Update
June 5 2025
Active Locations (11)
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1
Institut Bergonie
Bordeaux, France
2
Centre Oscar Lambret
Lille, France
3
Chu de Limoges
Limoges, France
4
Centre Leon Berard
Lyon, France