Recruiting
Phase 2

Robotic Cytoreduction

Sponsor:

Mayo Clinic

Code:

NCT05753306

Conditions

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Metastatic Malignant Neoplasm in the Peritoneum

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cisplatin

Computed Tomography

Gastrectomy

Magnetic Resonance Imaging

Positron Emission Tomography

Study Details

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.

Conditions

Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Metastatic Malignant Neoplasm in the Peritoneum

Study ID

NCT05753306

Start date

Apr 20, 2023

Status verified date

Apr, 2026

Completion date

Mar 25, 2030

Anticipated

Primary completion date

Mar 25, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (gastrectomy, HIPEC)

Patients undergo collection of stool and blood sample before and after surgery. Patients also undergo robotic gastrectomy and HIPEC with docetaxel and cisplatin on study. Patients undergo CT, MRI, or PET/CT scans throughout the trial.

Interventions

Cisplatin

Given via HIPEC

Computed Tomography

Undergo CT scan or PET/CT

Gastrectomy

Undergo robotic gastrectomy

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PE/CT

Questionnaire Administration

Complete questionnaire

Paclitaxel

Given via HIPEC

Hyperthermic Intraperitoneal Chemotherapy

Undergo HIPEC

Primary outcome measure

  • Hospital length of stay [ Time Frame: Up to 30 days post-surgery ]
  • 30 day readmission rate [ Time Frame: Up to 30 days post-surgery ]
  • Adverse Events [ Time Frame: Up to 30 days post surgery ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Travis E. Grotz, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-08.