2024-515981-14-00招募中3 期
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) in multimodal therapy for patients with oligometastatic peritoneal gastric cancer: a randomized multicenter phase III trial. PIPAC_VEROne
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 6
- 主要终点
- Secondary Resectability Rate (%) evaluated as the % of patients in the 2 arms who will go to CRS and HIPEC compared to the total number of participants at the end of 6 or 12 cycles of chemotherapy in the Arm A and at the end of the 6 cycles of chemotherapy and the 3 PIPACs in arm B; PFS at 1 and 3 years measured as time from randomization at the first evidence of progression (peritoneal or extraperitoneal) or death of patient for any cause, whichever comes first.
研究概览
简要总结
To evaluate whether the association of PIPAC with chemotherapy compared to chemotherapy alone increases the percentage of patients who undergo surgery with radical intent (CRS and HIPEC). To evaluate whether the association of PIPAC with chemotherapy compared to chemotherapy alone increases the progression-free survival (PFS).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age between 18-75 years
- •Primary gastric adenocarcinoma of first diagnosis not previously treated
- •Laparoscopic finding of positive peritoneal cytology and / or peritoneal localizations of disease (PCI ≤ 6), confirmed by histological examination
- •Signature of informed consent
- •ECOG PS scale 0-1
- •Patients of childbearing potential will be included in the study and monitored by serum pregnancy tests before each chemotherapy cycle and each PIPAC and at the end of treatment. Oral contraceptives will not be used due to the already high thrombotic risk related to the disease, but all other contraceptives will be used according to CTFG indications on contraception.
排除标准
- •Presence of extraperitoneal metastases
- •hypersensitivity to the active substances or to any of the excipients
- •liver failure (AST) / ALT> 3 times normal values, ALT> 3 times normal values, Bilirubin> 1.5 normal values)
- •Creatininemia> 1.25 mg / dL
- •Ischemic / haemorrhagic stroke within the past 6 months • Acute myocardial infarction within the past 6 months • Moderate / severe heart failure (NYHA III-IV)
- •Leukopenia <2,000 / µl • Thrombocytopenia <100,000 / µl
- •Active hepatitis B or C
- •HIV infection
- •creatinine clearance less than 30ml / min
- •Localization of the primary site of disease in the gastric esophagus junction of esophageal relevance (Siewert I-II)
- •Previous allergic reactions to cisplatin or doxorubicin
- •Haemorrhagic or occlusive manifestation of disease that candidates the patient for palliative surgery
- •Refusal of the patient to sign the consent
- •positive on diagnostic biopsies for EBV, MSI and HER2
- •pregnancy and breastfeeding
结局指标
主要结局
Secondary Resectability Rate (%) evaluated as the % of patients in the 2 arms who will go to CRS and HIPEC compared to the total number of participants at the end of 6 or 12 cycles of chemotherapy in the Arm A and at the end of the 6 cycles of chemotherapy and the 3 PIPACs in arm B; PFS at 1 and 3 years measured as time from randomization at the first evidence of progression (peritoneal or extraperitoneal) or death of patient for any cause, whichever comes first.
Secondary Resectability Rate (%) evaluated as the % of patients in the 2 arms who will go to CRS and HIPEC compared to the total number of participants at the end of 6 or 12 cycles of chemotherapy in the Arm A and at the end of the 6 cycles of chemotherapy and the 3 PIPACs in arm B; PFS at 1 and 3 years measured as time from randomization at the first evidence of progression (peritoneal or extraperitoneal) or death of patient for any cause, whichever comes first.
次要结局
- overall survival at 1 and 3 years, measured as survival time from randomization until death from any cause; this endpoint will be compared between the two treatment arms
- DRS at 1 and 3 years measured as survival time from randomization until cancer-related death; this endpoint will be compared between the two treatment arms
- For each patient in Arm B, starting from second cycle of PIPAC, a PRGS score will be assigned for each of the 4 biopsies performed, associated with an average PRGS score, given by the arithmetic mean of the individuals scores. In Arm A, this evaluation can only be carried out on the first occasion restaging after 3 months of treatment on biopsies performed during laparoscopy restaging or at the end of 6 months in those patients with stable disease who continued treatment chemotherapy
- Degree of histological regression on the surgical specimen assessed using Tumor Regression Grade (TRG) sec. Mandard and compared between the two treatment arms in patients who will undergo cytoreduction and HIPEC
- The quality of life QoL assessed using the validated EORTC QLQ C30 questionnaire, administered to the patient at the beginning of recruitment and after each treatment cycle or PIPAC and compared between the two treatment arms
- Adverse events assessed by CTCAE v.5 after each treatment cycle and after each PIPAC and compared between the two treatment arms
- Calculation of incremental cost-effectiveness ratios (Incremental Cost-Effectiveness Ratio= ICER) per additional resectable case and per year of life gained
研究者
Francesco Casella
Scientific
Azienda Ospedaliera Universitaria Integrata Verona
研究点 (6)
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