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

Launched by MAYO CLINIC · Mar 2, 2023

Keywords

ClinConnect Summary

The ROBO-CHIP study is a clinical trial that is exploring a new treatment approach for patients with gastric cancer that has spread to the lining of the abdomen, known as peritoneal metastasis. This trial combines two methods: robotic surgery, which allows doctors to perform the operation through small cuts instead of a large incision, and a special heated chemotherapy treatment delivered directly into the abdominal cavity during surgery. This combination aims to improve recovery times and reduce complications compared to traditional surgery.

To participate in this trial, patients need to be between 18 and 80 years old, have a confirmed diagnosis of gastric adenocarcinoma, and show that their cancer is limited to the peritoneum. They should also have a good overall health status and meet specific blood and body weight criteria. Participants can expect to undergo robotic surgery and receive heated chemotherapy during the procedure, with careful monitoring and support throughout the process. This study is currently recruiting participants, and it is important for those interested to discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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
• * 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
• Exclusion Criteria:
• • 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