Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Probability of occurrence of a significant adverse event related to the central venous device
研究概览
简要总结
Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade...). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.
The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.
详细描述
The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age > 18
- •Documented breast cancer
- •No Her2 overexpression
- •Patients operated with curative intent (no distant metastasis at diagnosis)
- •Patients undergoing an adjuvant chemotherapy consisting of 3 courses of FEC 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of Taxotere, or 6FEC100 (according to CHB refencial for localised breast cancer treatment).
- •Signed informed consent
排除标准
- •Bilateral axillary node dissection
- •History of bilateral upper thoracic irradiation
- •Cutaneous disease (eczema, scleroderma, infection...) at catheter insertion site (arm or upper thorax)
- •Recent thrombosis of the upper body
- •Therapeutic anticoagulation
- •Tracheotomy
- •Treatment for bacteriemia in process
- •Altered hemostasis: INR > 1.5 ; APTT > 1.5 , platelets < 60 G/l
- •Renal failure with creatinine clearance < 60mL/min
- •Involvement in another trial
- •Contraindication to chemotherapy by FEC 100 or taxotere
- •Pregnancy or breast feeding
- •Protected major patient (under guardianship).
- •Psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french
研究组 & 干预措施
PICC line
Use of a PICC line for chemo administration (PowerPICC SOLO²)
干预措施: Use of a PICC line for chemo administration (PowerPICC SOLO²) (Device)
Implanted Port
Use of an implanted port for chemo administration
干预措施: implanted port for chemo administration (X-port isp) (Device)
Implanted Port
Use of an implanted port for chemo administration
干预措施: Use of a PICC line for chemo administration (PowerPICC SOLO²) (Device)
结局指标
主要结局
Probability of occurrence of a significant adverse event related to the central venous device
时间窗: 37 weeks
To define between the two device (PICC line and implanted port) which one provides the less probability of occurrence of a significant adverse event related to the device (SAERD), from the insertion to the first consultation of survey (36-38 weeks after implantation of the device which is also 5 months after its ablation).
次要结局
- Patients' satisfaction for the use of their central venous device(1 year)