Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 10
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The most common site for gastric cancer distant metastases is the peritoneum. Median survival for this group of patients is short and systemic cytotoxic treatment response is poor, partly due to the low uptake of the treatment compounds to the peritoneum during systemic chemotherapy. Infusion of cytotoxic drugs directly into the abdominal cavity has been shown to have a high objective response rate and low toxicity. The IPa-Gastric trial is an open-label, multicentre, randomised, phase-III study in the first line setting in gastric cancer patients with peritoneal metastases. Patients will receive the study treatments until disease progression, unacceptable side effects, the investigator's decision to end treatment for other reasons, death, or end of study. After discontinuing study treatments, each patient will be followed up for all study endpoints that are clinically feasible, until death or end of study. The primary objective is to compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard ST versus those randomised to standard ST only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
- •Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
- •Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
- •Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy.
- •Adequate hematology assessment and serum chemistry
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Age of at least 18 years
- •Life expectancy of at least three months
- •Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable
排除标准
- •Comorbidity that does not allow treatment with ST or IP paclitaxel
- •Confirmed or suspected severe abdominal adhesions
- •Severe coagulation disorder which precludes surgical interventions
- •Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases
- •Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term
- •Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery
- •Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to 2 cycles of first line chemotherapy is allowed). Perioperative chemotherapy within previous curative context is allowed
- •Another malignancy that can affect survival within the next three years
- •Known or suspected allergies against any product included in the trial interventions
- •DYPD deficiency
- •Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding
- •Active sex-life without use of secure contraceptive method.
- •If the investigator considers the patient inappropriate for participation in the study for any other reason
- •Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product
研究组 & 干预措施
Intraperitoneal paclitaxel + Standard systemic therapy
The experimental arm treatment will consist of the same standard systemic investigator's choice treatment described above combined with IP paclitaxel.
干预措施: Intraperitoneal Paclitaxel (Drug)
Intraperitoneal paclitaxel + Standard systemic therapy
The experimental arm treatment will consist of the same standard systemic investigator's choice treatment described above combined with IP paclitaxel.
干预措施: Standard systemic therapy (Drug)
Standard systemic therapy
The control arm treatment in the study will consist of standard investigator's choice therapy with systemic chemotherapy and any targeted therapies indicated in the standard clinical practice setting
干预措施: Standard systemic therapy (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Assessed every second month from randomization until study completion, during a maximum of 60 months.
Overall survival (OS), defined as time from randomisation to death from any cause. For subjects who are still alive at the End of Study (EoS), or who are lost to follow up, OS time will be censored at the last recorded date that the subject was known to be alive.
次要结局
- Treatment-related toxicity(Assessed continously from start of treatment until 4 weeks after end of treatment for respective participant, during a maximum of 61 months.)
- General Health Related Quality of Life (HR QoL)(Assessed at baseline and 2, 4, 6, 12 and 24 months after randomisation)
- Progression free survival (PFS)(Assessed from randomization until study completion, during a maximum of 60 months.)
- Radiological response of treatment on ascites present at baseline.(Assessed from baseline visit until study completion, during a maximum of 60 months.)
- Paracentesis of ascites(Assessed from randomization until study completion, during a maximum of 60 months.)
- Amount of ascites drained(Assessed from time of randomisation to study completion, during a maximum of 60 months.)
- Proportion of patients fulfilling the criteria for curative intent conversion surgery.(Assessed from randomisation until study completion, during a maximum of 60 months.)
- The proportion of patients undergoing conversion surgery(Assessed from randomisation until study completion, during a maximum of 60 months.)
研究者
Magnus Nilsson
Head of the Division of Surgery and Oncology
Karolinska University Hospital