A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
Mayo Clinic
Summary
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
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Respon…
Interventions
- DrugCisplatin
Given via HIPEC
- ProcedureComputed Tomography
Undergo CT scan or PET/CT
- ProcedureGastrectomy
Undergo robotic gastrectomy
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PE/CT
- OtherQuestionnaire Administration
Complete questionnaire
- DrugPaclitaxel
Given via HIPEC
Location
- Mayo Clinic in RochesterRochester, Minnesota