Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Objective tumor response according to RECIST v 1.1 after second PIPAC
研究概览
简要总结
Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.
详细描述
This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
- •Patient willing to participate;
- •Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.
排除标准
- •Extra-abdominal metastases;
- •Siewert I type gastroesophageal junction cancer;
- •Mechanical bowel obstruction;
- •Allergy to study drugs;
- •History of previous intraperitoneal chemotherapy;
- •Pregnancy of refusal for birth-control at least 6 months post-study treatment
研究组 & 干预措施
Experimental treatment
Each patient will be scheduled for 3 courses of combined treatment: in total 3 PIPAC with cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 and 6 cycles of FOLFOX systemic chemotherapy.
干预措施: Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy (Drug)
结局指标
主要结局
Objective tumor response according to RECIST v 1.1 after second PIPAC
时间窗: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)
Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure
次要结局
- Tumor markers(Through study completion, an average of 28 months)
- Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).(Through study completion, an average of 28 months)
- Ascites volume(Through study completion, an average of 28 months)
- Overall survival(From treatment start to death, assessed up to 24 months)
- Postoperative complication assessed by Clavien-Dindo score(Through study completion, an average of 28 months)
- Progression-free survival(From treatment start to death, assessed up to 24 months)
- Compliance to treatment(Through study completion, an average of 28 months)
- Adverse events of chemotherapy drugs(Through study completion, an average of 28 months)
- Objective tumor response according to RECIST v 1.1(Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study))
- Quality of life by EORTC questionnaires(Through study completion, an average of 28 months)
研究者
Martynas Luksta
Abdominal surgeon
Vilnius University