NCT04680715招募中2 期
Per-Operative Radiotherapy (RPO) by Papillon +TM in Localized Breast Cancer : Faisability and Toxicity Study
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- early toxicities occuring until 6 months after performing per-operative radiotherapy
研究概览
简要总结
Phase II study; open recruitment, multicentrique. The aim of this clinical research is to evaluate faisability and toxicity of the per-operative radiotherapy using PAPILLON + TM device for localized breast cancers patients over 65 years.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with invasive ductal adenocarcinoma <=2cm, evaluate on all radiological exams;
- •Women aged 65 years or older (patients 65 years of age in the year may be included);
- •Grade 1 or 2 unifocal adenocarcinoma, all index KI67, positive HR, negative HER2 status;
- •T0 or T1, N0 radio-clinic;
- •Operable patient with breast volume compatible with conservative surgery;
- •Patient with prior malignancy or other concurrent malignancies are eligible, including bilateral breast cancer
- •Patients who have been made aware of the information sheet and have given their written signed informed consent;
- •Patients benefitting from social health insurance coverage
排除标准
- •Age less than 65 years (except if 65 years obtained during the year)
- •Patient with an exclusive in situ carcinoma
- •Patient with lymphatic invasion / peri-nerve involvement / vascular emboli
- •Patient with a lobular adenocarcinoma
- •Patient with metastatic disease
- •Multifocal tumor
- •Patient with grade 3 or N+ disease
- •N1 proved by ultrasound guided
- •patient unable to express her consent
- •Patient deprived placed under the authority of a tutor
- •Female patients who are pregnant or breastfeeding
- •Vulnerable patient: as defined in article L1121-5 à -8
研究组 & 干预措施
Per-Operative Radiotherapy technique by Papillon +TM
Experimental
Per-Operative Radiotherapy (1x20Gy) technique by Papillon +TM
干预措施: Per-Operative Radiotherapy technique by Papillon +TM (Radiation)
结局指标
主要结局
early toxicities occuring until 6 months after performing per-operative radiotherapy
时间窗: up to 6 months
pourcentage of patient with toxicities of grade 3 and more (by CTCAE v5.0) related to per-operative radiotherapy and that occured until 6 months after performing
次要结局
- global tolerance of per-operative radiotherapy(up to 5 years)
- disease free survival at 5 years of per-operative radiotherapy(up to 5 years)
- quality of life of patients(up to 6 months)
- local disease free survival at 5 years of per-operative radiotherapy(up to 5 years)
研究者
研究点 (2)
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