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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.
Sponsor: Institut Claudius Regaud
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).
Official title: 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.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2023-11-28
Completion Date
2029-05
Last Updated
2025-06-05
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated Radiation Therapy
The Hypofractionated Intensity-Modulated Radiation Therapy will be delivered in 5 fractions of 6 Gy each on the Planning Target Volume (PTV). The total dose of 30 Gy will be administered in approximately 1 week.
Conservative treatment
A wide en bloc resection is required (amputation is excluded) while ensuring the best functional preservation. The surgical procedure will take place about 1,5 to 2 months after the end of the radiation therapy.
Locations (11)
Institut Bergonie
Bordeaux, France
Centre Oscar Lambret
Lille, France
Chu de Limoges
Limoges, France
Centre Leon Berard
Lyon, France
Institut Regional Du Cancer de Montpellier
Montpellier, France
Institut Curie
Paris, France
Chu de Poitiers
Poitiers, France
Institut de Cancerologie de L'Ouest
Saint-Herblain, France
Chu de Toulouse
Toulouse, France
IUCT-O
Toulouse, France
Institut Gustave Roussy
Villejuif, France