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.

Официальное название

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.

Обзор

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).

Вмешательства

• Лучевая терапия 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.
• Процедура 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.

Первичные конечные точки

• The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery. [Срок оценки: 6 month for each patient]

Вторичные конечные точки (10)

• 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. [Срок оценки: 3 years for each patient]
• Surgical complications evaluated according to NCI CTC AE V5 criteria. [Срок оценки: 3 years for each patient]
• Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent. [Срок оценки: 3 years for each patient]
• Healing time defined as the time between the date of surgery and the date of complete healing. [Срок оценки: 3 years for each patient]
• Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30). [Срок оценки: 3 years for each patient]
• Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14). [Срок оценки: 3 years for each patient]
• Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire. [Срок оценки: 3 years for each patient]
• Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire. [Срок оценки: 3 years for each patient]
• Geriatric parameters evaluated using the G-CODE questionnaire. [Срок оценки: 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. [Срок оценки: 3 years for each patient]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 11 центров

• Institut Bergonie — Bordeaux
• Centre Oscar Lambret — Lille
• Chu de Limoges — Limoges
• Centre Leon Berard — Lyon
• Institut Regional Du Cancer de Montpellier — Montpellier
• Institut Curie — Paris
• Chu de Poitiers — Poitiers
• Institut de Cancerologie de L'Ouest — Saint-Herblain
• … и ещё 3 центра

Идентификаторы

NCT: NCT06022159 · 23 SARC 01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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