Informations générales (source: ClinicalTrials.gov)
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.
Interventional
Phase 2
Institut Claudius Regaud (Voir sur ClinicalTrials)
novembre 2023
mai 2029
03 juin 2026
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | C�cile LE PECHOUX | 28/06/2024 08:03:39 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | C�cile LE PECHOUX | 10/07/2026 12:10:05 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Leon Berard - Lyon - France | Waisse WAISSI | Contact (sur clinicalTrials) | |||
| Chu de Poitiers - Poitiers - France | Sarah GARCIA MOLINA | Contact (sur clinicalTrials) | |||
| Chu de Toulouse - Toulouse - France | Louis COURTOT | Contact (sur clinicalTrials) | |||
| Institut de Cancerologie de L'Ouest - Saint-Herblain - France | Augustin MERVOYER | Contact (sur clinicalTrials) | |||
| IUCT-O - Toulouse - France | Justine ATTAL KHALIFA | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Oscar Lambret - Lille - France | Abel CORDOBA LARGO | Contact (sur clinicalTrials) | |||
| Chu de Limoges - Limoges - France | Hélène ORLIAC | Contact (sur clinicalTrials) | |||
| Institut Bergonie - Bordeaux - France | Pauline GILLON | Contact (sur clinicalTrials) | |||
| Institut Regional Du Cancer de Montpellier - Montpellier - France | Carmen LLACER-MOSCARDO | Contact (sur clinicalTrials) | |||
Critères
Tous
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).