About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Cisplatin
DrugGiven via HIPEC
Computed Tomography
Procedure/SurgeryUndergo CT scan or PET/CT
Gastrectomy
Procedure/SurgeryUndergo robotic gastrectomy
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Positron Emission Tomography
Procedure/SurgeryUndergo PE/CT
Questionnaire Administration
Other interventionComplete questionnaire
Paclitaxel
DrugGiven via HIPEC
Hyperthermic Intraperitoneal Chemotherapy
DrugUndergo HIPEC
Treatment groups
Trial outcomes
Primary outcomes
Hospital length of stay
Recorded as number of days in hospital following surgery.
30 day readmission rate
Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery
Adverse Events
Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)
Secondary outcomes
Operative time
Recorded as the time from incision to close
Opioid consumption
Assessed by morphine milligram equivalents during hospitalization and post-surgical recovery.
Nursing reported pain scores
As recorded (mean and max) during hospitalization and post-surgery follow-up visits
Recurrence-Free Survival (RFS)
Assessed from the date of gastrectomy and hyperthermic intraperitoneal chemotherapy (HIPEC). Patterns of tumor recurrence will be assessed by reviewing routine surveillance imaging.
Sponsors and contacts
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