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

Phase

Condition

Gastric Ulcers

Gastric Cancer

Neoplasms

Treatment

Paclitaxel

Biospecimen Collection

Magnetic Resonance Imaging

Clinical Study ID

NCT05753306

22-004680

NCI-2023-00431

22-004680

Ages 18-80
All Genders

Study 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 Criteria

Inclusion

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 Siewerttype 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 EvaluationCriteria in Solid Tumors (RECIST) criteria]
Reduction in size of primary tumor, regional lymph node or peritonealmetastasis on imaging (>= 20% decrease in the longest diameter of targetlesion) RECIST criteria
Reduction ( >= 30%) in Peritoneal Carcinomatosis Index (PCI) or conversion ofperitoneal cytology
Reduction ( >= 30%) in serum tumor markers CEA or CA 19-9
Peritoneal Carcinomatosis Index (PCI) =< 7 and surgeon deems high likelihood for acomplete cytoreduction
Body Mass Index (BMI) =< 35 kg/m^2

Exclusion

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 waslife-threatening, required hospitalization or prolongation of existinghospitalization, or resulted in persistent or significant disability or incapacity

Study Design