NCT06022159招募中2 期
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.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 12
- 主要终点
- The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Radiation therapy followed by surgery
Experimental
干预措施: Hypofractionated Radiation Therapy (Radiation)
Radiation therapy followed by surgery
Experimental
干预措施: Conservative treatment (Procedure)
结局指标
主要结局
The rate of patients free of major surgical complications as defined by O'Sullivan within 6 months of surgery.
时间窗: 6 month for each patient
次要结局
- Toxicities of the radiation therapy evaluated according to NCI CTC AE V5 criteria and Radiation Therapy Oncology Group (RTOG) classification.(3 years for each patient)
- Geriatric parameters evaluated using the G8 (Geriatric 8) questionnaire.(3 years for each patient)
- Geriatric parameters evaluated using the G-CODE questionnaire.(3 years 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.(3 years for each patient)
- Surgical complications evaluated according to NCI CTC AE V5 criteria.(3 years for each patient)
- Wound disorders, such as partial necrosis and scar disunion, classified into four categories: severe, moderate, minor, absent.(3 years for each patient)
- Healing time defined as the time between the date of surgery and the date of complete healing.(3 years for each patient)
- Patients' quality of life evaluated using the EORTC questionnaire (QLQ-ELD14).(3 years for each patient)
- Patients' quality of life evaluated using the EORTC questionnaire (QLQ-C30).(3 years for each patient)
- Patient autonomy evaluated using the IADL (Instrumental Activities of Daily Living) questionnaire.(3 years for each patient)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
STEREO-POSTOP 01 (PostOperative Hypofractionated Stereotactic Body Radiotherapy ) - GORTEC 2017-03Head and Neck NeoplasmsNCT03401840Centre Jean Perrin90
已完成
2 期
Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44)Pancreatic CarcinomaNCT02676349Institut de Cancérologie de Lorraine130
已完成
2 期
A Study Evaluating the Efficacy and Safety of HSK21542 Injection for Analgesia in Subjects Undergoing ColonoscopyAnalgesiaNCT04470128Haisco Pharmaceutical Group Co., Ltd.180
已完成
2 期
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid TumorsPancreas CancerCholangiocellular CarcinomaBladder CancerNCT02999672Hoffmann-La Roche20
Unknown
2 期
Phase II Study in the Treatment of Patients With Advanced Mucinous MelanomaAdvanced Mucosal MelanomaNCT03941795Peking University Cancer Hospital & Institute99