A Study to Evaluate Hyperthermic Intraperitoneal Chemotherapy to Treat Patients with Pancreatic Cancer and Peritoneal Metastasis

Overview

About this study

The primary purpose of this study is to assess short-term morbidity and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing 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:

  • Age ≥ 18 but  ≤ 80 years old.
  • ECOG performance status ≤ 2. 
  • Cytologic or histologic proof of adenocarcinoma of the pancreas.
  • Adequate renal, and bone marrow function:
    • Leukocytes ≥ 3,000/uL;
    • Absolute neutrophil count ≥ 1,500/uL;
    • Platelets ≥ 60,000/Ul;
    • Serum creatinine ≤ 1.5 mg/dL.
  • Distant metastatic disease of peritoneum may be visualized on imaging:
    • Positive peritoneal cytology;
    • Limited carcinomatosis on diagnostic laparoscopy or laparotomy;
    • KRASD assay positive peritoneal washings/cytology.
  • Completion of preoperative systemic chemotherapy with biochemical, metabolic, and/or radiographic response defined as a reduction in the baseline CA 19-9 by > 50% or radiographic response as defined by RECIST 1.1 or metabolic response on PET-MRI defined by PERCIST criteria.
  • Peritoneal Carcinomatosis Index (PCI) ≤ 7 and surgeons deems high likelihood for a complete cytoreduction.

Exclusion Criteria:

  • Distant metastatic disease not limited to peritoneum:
    • Solid organ metastases (liver, central nervous system, lung).
  • Infections such as pneumonia or wound infections 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 life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.

Eligibility last updated 11/22/21. Questions regarding updates should be directed to the study team contact.

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.

Contact us for the latest status

Contact information:

Danielle Patnode B.S.

(507) 538-4110

Patnode.Danielle@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions