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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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.
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.
Institut Bergonie
Bordeaux, France
RECRUITINGCentre Oscar Lambret
Lille, France
RECRUITINGChu de Limoges
Limoges, France
RECRUITINGCentre Leon Berard
Lyon, France
RECRUITINGInstitut Regional Du Cancer de Montpellier
Montpellier, France
RECRUITINGInstitut Curie
Paris, France
NOT_YET_RECRUITINGChu de Poitiers
Poitiers, France
RECRUITINGInstitut de Cancerologie de L'Ouest
Saint-Herblain, France
RECRUITINGChu de Toulouse
Toulouse, France
RECRUITINGIUCT-O
Toulouse, France
RECRUITING...and 1 more locations
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
Time frame: 6 month for each patient
Patients' disease-free survival defined as the time between the inclusion date and the occurrence of a carcinological event (local recurrence, distant metastasis) or death from any cause.
Time frame: 3 years for each patient
Surgical complications evaluated according to NCI CTC AE V5 criteria.
Time frame: 3 years for each patient
Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.
Time frame: 3 years for each patient
Healing time defined as the time between the date of surgery and the date of complete healing.
Time frame: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).
Time frame: 3 years for each patient
Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).
Time frame: 3 years for each patient
Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.
Time frame: 3 years for each patient
Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.
Time frame: 3 years for each patient
Geriatric parameters evaluated using the G-CODE questionnaire.
Time frame: 3 years for each patient
Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.
Time frame: 3 years for each patient
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