Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMayo Clinic

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

Qualifiers

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

Treatments tested in this trial

  • Cisplatin
  • Computed Tomography
  • Gastrectomy
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Questionnaire Administration
  • Paclitaxel
  • Hyperthermic Intraperitoneal Chemotherapy

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators