Study of Gastric Cancer and Limited Peritoneal Metastasis Using Robotic Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy

Overview

About this study

The purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with gastric adenocarcinoma with limited low volume peritoneal metastasis and/or positive peritoneal cytology undergoing robotic cytoreduction and hyperthermic intraperitoneal chemotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Restricted to 18 to 80 years of age.
  • ECOG performance status ≤ 2.
  • Histologic confirmation of gastric adenocarcinoma including all subtypes and Siewert type III GE junction adenocarcinomas
  • Adequate renal, and bone marrow function:
    • Leukocytes ≥ 3,000/uL;
    • Absolute neutrophil count ≥ 1,500/uL;
    • Platelets ≥ 50,000/Ul d. Serum creatinine ≤ 1.5 mg/dL.
  • 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 SUV max;
    • Reduction in size of primary tumor, regional lymph node or peritoneal metastasis on imaging (≥ 30% decrease in the longest diameter of target lesion) or laparoscopy (reduction in 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.
  • 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.
  • Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
  • Subjects deemed unable to comply with study and/or follow-up procedures.
  • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was lifethreatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity. 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Travis Grotz, M.D.

Open for enrollment

Contact information:

Summer Auerbach

(507) 422-9153

Auerbach.Summer@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20544828

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