A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
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.
Arms & 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
- DrugHyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC
Outcome measures
Primary
Hospital length of stay
Recorded as number of days in hospital following surgery.
Time frame: Up to 30 days post-surgery
30 day readmission rate
Assessed by the number of participants who are re-admitted to the hospital after being discharged post-surgery
Time frame: Up to 30 days post-surgery
Adverse Events
Assessed by Clavien-Dindo Classification (grade 1-5, grade 1 being least severe and grade 5 being death)
Time frame: Up to 30 days post surgery
Secondary
Operative time
Time frame: Intraoperative
Opioid consumption
Time frame: Up to 3 years
Nursing reported pain scores
Time frame: Up to 3 years
Recurrence-Free Survival (RFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905