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

Overview

Información sobre este estudio

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.

 

 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Cornelius Thiels, D.O., M.B.A.

Abierto para la inscripción

Contact information:

Travis Fisher

(507) 538-4110

fisher.travis1@mayo.edu

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

Preguntas de estudios clínicos para pacientes internacionales