Neoadjuvant Systemic and Peritoneal Chemotherapy for Regionally Advanced Gastric Cancer With Minimal Peritoneal Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility and safety of combined neoadjuvant systemic chemotherapy and pressurised intraperitoneal aerosol chemotherapy (PIPAC)
研究概览
简要总结
Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis.
Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile.
Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).
详细描述
BACKGROUND:
There remains therefore an important, and as yet unmet, clinic need to improve survival of patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease.
To address this challenge, there has been emerging interest in the use of intraperitoneal chemotherapy for the treatment and suppression of peritoneal disease in patients with regionally advance gastric cancer.
HYPOTHESIS:
Use of combined neoadjuvant systemic chemotherapy and PIPAC in a highly selected group of patients with locally advanced gastric cancer (positive cytology and/or minimal peritoneal disease) is safe and will effectively eradicate all traces of peritoneal metastasis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric adenocarcinoma (Tx, Nx) 1,2,3
- •Peritoneal cytology +ve or PCI ≤ 3
- •No solid organ metastasis 2
- •Male/female
- •Treatment naïve
- •BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2
- •WHO performance status ≤ 1
- •Dysphagia score ≤ 2
- •Informed written consent
排除标准
- •Solid organ metastasis
- •Positive lymph node disease beyond field of D2 lymphadenectomy
- •Peritoneal adhesions precluding complete laparoscopy
- •Ascites (greater than trace amount)
- •Malignant pleural effusion
- •Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
- •Patients eligible for immunotherapy
- •Uncontrolled co-morbidity
- •single/multiple organ failure
- •BMI < 18.5 kg/m2 or > 40 kg/m2
- •WHO performance status > 1
- •Dysphagia score > 2
- •Contraindication to chemotherapy
- •Pregnancy or breastfeeding
- •Haemoglobin <90 g/dL uncorrected with blood transfusion
研究组 & 干预措施
Neoadjuvant systemic and peritoneal chemotherapy
Standard neoadjuvant systemic and pressurised intraperitoneal aerosol chemotherapy
干预措施: Doxorubicin and Cisplatin (Drug)
结局指标
主要结局
Feasibility and safety of combined neoadjuvant systemic chemotherapy and pressurised intraperitoneal aerosol chemotherapy (PIPAC)
时间窗: 2 years
Barrier and mitigating factors or the provision of combined neoadjuvant systemic chemotherapy and PIPAC will be assessed. Safety of this intervention in terms of risks to patients and staff will also be evaluated.
次要结局
- Tumour regression(2 years)
- Health related quality of life(2 years)
- Patient morbidity(2 years)
- Disease recurrence and survival(5 years)