A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hospital length of stay
研究概览
简要总结
This phase II clinical trial tests how well robotic cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with gastric cancer that has spread to the tissue that lines the wall of the abdominal cavity (peritoneum). Gastric cancer is the third leading cause of cancer related deaths worldwide and peritoneal metastasis are found in 30% of patients at time of diagnosis. Patients with peritoneal metastasis have poor survival rates. Traditional surgery is done with a large incision and has a high complication rate and longer hospital stays. Robot assisted (robotic) cytoreduction is a surgical option that uses small incisions and there is less risk of complications. HIPEC involves infusing heated chemotherapy into the abdominal cavity during surgery. Robotic cytoreduction together with HIPEC may improve recovery and decrease complications after surgery.
详细描述
PRIMARY OBJECTIVE:
I. To assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.
SECONDARY OBJECTIVES:
I. To obtain a biorepository for additional translational research including:
Ia. Stool samples for shotgun metagenomic sequencing and metabolomic quantification of the fecal microbiome before and after gastrectomy; Ib. Blood and peritoneal tissue biobanked for future investigations; Ic. Patient reported outcomes using the Mayo Clinic Upper Digestive Disease Survey questionnaires at 1, 3, 6 and 12 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Restricted to 18 to 80 years of age
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type II/III gastroesophageal (GE) junction adenocarcinomas
- •Absolute neutrophil count >= 1,500 / uL
- •Platelets >= 50,000 / Ul
- •Serum creatinine <= 1.5 mg / dL
- •Adequate nutritional status (Albumin >= 3.5)
- •Metastasis confined to the peritoneum:
- •Positive peritoneal cytology
- •Peritoneal metastasis on diagnostic laparoscopy
- •Peritoneal metastasis on imaging
- •Response to systemic chemotherapy defined as at least one of the following:
- •Reduction (>= 30%) in standardized uptake value (SUV) max [Response Evaluation Criteria in Solid Tumors (RECIST) criteria]
- •Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (>= 20% decrease in the longest diameter of target lesion) RECIST criteria
- •Reduction ( >= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion of peritoneal cytology
- •Reduction ( >= 30%) in serum tumor markers CEA or CA 19-9
- •Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeon deems high likelihood for a complete cytoreduction
- •Body Mass Index (BMI) =< 35 kg/m^2
排除标准
- •Distant metastatic disease not limited to peritoneum, such as solid organ metastases (liver, lung, bone, distant lymph node, etc)
- •Malignant ascites at time of study enrollment
- •Comorbidities that would preclude protocol therapy
- •Subjects deemed unable to comply with study and/or follow-up procedures
- •Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
研究组 & 干预措施
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Hyperthermic Intraperitoneal Chemotherapy (Drug)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Paclitaxel (Drug)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Cisplatin (Drug)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Computed Tomography (Procedure)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Gastrectomy (Procedure)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Positron Emission Tomography (Procedure)
Treatment (gastrectomy, HIPEC)
Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Hospital length of stay
时间窗: Up to 30 days post-surgery
Recorded as number of days in hospital following surgery.
30 day readmission rate
时间窗: Up to 30 days post-surgery
Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery
Adverse Events
时间窗: Up to 30 days post surgery
Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)
次要结局
- Opioid consumption(Up to 3 years)
- Nursing reported pain scores(Up to 3 years)
- Recurrence-Free Survival (RFS)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
- Operative time(Intraoperative)
- Opioid consumption(Up to 42 months)
- Nursing reported pain scores(Up to 42 months)