Breast Cancer Plasma Adjuvant Intra-operative Treatment (Breast Cancer PAINT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Incremental increase of NTP dose to reach maximum safe dose.
研究概览
简要总结
The goal of this clinical trial is to test the safety of the use of non-thermal plasma (NTP, an ionized gas) on the tumor bed after the removal of the tumor in breast cancer patients. The main questions it aims to answer are:
- To determine the safe and tolerable dose of NTP in patients with breast cancer;
- To assess the safety and tolerability of NTP;
- To assess the cosmetic effects of NTP treatment in patients with breast cancer. Participants will receive one treatment of the tumor bed after the removal of their breast tumor.
详细描述
Non-thermal plasma (NTP) refers to an ionized gas composed of ions, electrons and other reactive agents. The anti-cancerous properties of NTP have been proven in vitro and in vivo. The 10-year local recurrence risk (LRR) in breast cancer patients after a breast conservation therapy (i.e., lumpectomy, typically followed by radiation therapy) is still as high as 15-20%. NTP could be used to further treat the tumor bed to reduce the LRR.
The primary objective of this clinical trial is to determine the safe and tolerable dose of NTP treatment following breast cancer lumpectomy. The secondary objectives are to assess the safety and tolerability of NTP and to assess the cosmetic effects of NTP treatment in patients with breast cancer. Our exploratory objective is to assess the impact of NTP treatment on cancerous and normal tissues. Patients are followed for 3 months after NTP treatment. The patients are divided into 3 groups: group A (n=3): NTP treatment of part of the tumor bed ex vivo. Group B (n=3): NTP treatment of part of the tumor bed in situ (all treated tissues are removed for analysis). Group C (n=6-24): dose escalation per "3+3 Design" up to a maximum dose level 3. NTP treatment of part of the tumor bed in situ (the treated parts of the tumor bed will not be excised, except a small portion for analysis).
The safety and tolerability of treatment will be evaluated by means of dose limiting toxicities, adverse events (AEs) and serious adverse events reports, physical examinations, and laboratory safety evaluations. AEs will be coded according to the CTCAE v5.0. The results will be tabulated to examine their frequency, grade, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly. The number of patients with cosmetic alterations linked to the NTP treatment and type of alterations will be assessed through the quality of life questionnaires (questions on breast appearance and texture) and through the photo collection. This is the first clinical trail to study the safety and tolerability of NTP in an all breast-cancer patient group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥18 years at the time of signing study consent.
- •Patient with T1-4 breast cancer for groups A and B; patient with T1/T2 breast cancer for group C (based on physical exam, not radiological measurements).
- •Patient is scheduled to undergo a lumpectomy.
排除标准
- •Prior treatment for the tumor of interest (including chemotherapy, immunotherapy, radiotherapy).
- •Patient planning to or undergoing intraoperative radiotherapy.
- •Diabetes (types I and II).
- •Hypercortisolism.
- •Collagen vascular disease.
- •Patient requiring systemic corticosteroids at physiologic doses exceeding 10 mg/day of prednisone or its equivalent.
- •Patient receiving daily chemotherapy for rheumatological conditions.
- •Pregnancy (a urine pregnancy test must be obtained for non-sterile women of childbearing potential prior to surgery).
研究组 & 干预措施
NTP treatment
The patients will be treated with NTP intra-operatively.
干预措施: Convertible Plasma Jet (Device)
结局指标
主要结局
Incremental increase of NTP dose to reach maximum safe dose.
时间窗: 3 months
The safety and tolerability of treatment will be evaluated by means of dose-limiting toxicities, adverse events and serious adverse events reports, physical examinations, and laboratory safety evaluations. Dose-limiting toxicities are defined as a grade 4 fever, breast infection, skin ulceration or chest wall necrosis (according to CTCAE v5.0).
次要结局
- Number of patients with adverse events linked to the NTP treatment and type of events.(3 months)
- Number of patients with cosmetic alterations linked to the NTP treatment and type of alterations.(3 months)