Clinical trial NCT05753306: Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for Treatment of Gastric Cancer With Limited Peritoneal Metastasis, ROBO-CHIP Study
Official title: A Phase II Study of Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Gastric Cancer and Limited Peritoneal Metastasis: ROBO-CHIP Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Metastatic Malignant Neoplasm in the Peritoneum
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Hospital length of stay
timeFrame: Up to 30 days post-surgery
measure: 30 day readmission rate
timeFrame: Up to 30 days post-surgery
measure: Adverse Events
timeFrame: Up to 30 days post surgery
Secondary outcomes:
measure: Operative time
timeFrame: Intraoperative
measure: Opioid consumption
timeFrame: Up to 42 months
measure: Nursing reported pain scores
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Travis E Grotz, MD
role: PRINCIPAL_INVESTIGATOR
References: