RECRUITING

Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis

Talk to us

Conditions

Metastatic Pancreatic CarcinomaStage IV Pancreatic Cancer AJCC v8Metastatic Malignant Neoplasm in the Peritoneum

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial studies the effects of hyperthermic intraperitoneal chemotherapy (HIPEC) in treating patients with pancreatic cancer that has spread to the internal abdominal area (peritoneal metastasis). Chemotherapy drugs, such as nab-paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. HIPEC involves "heated" chemotherapy that is placed directly in the abdomen through laparoscopic instruments, instead of through an intravenous injection. This study may help doctors determine how safe and effective HIPEC work in treating patient with pancreatic cancer.

Official Title

A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis

Quick Facts

Study Start:2024-01-05
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04858009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>= 18 but =\< 80
  2. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  3. * Cytologic or histologic proof of adenocarcinoma of the pancreas
  4. * Leukocytes \>= 3,000/uL
  5. * Absolute neutrophil count \>= 1,500/uL
  6. * Platelets \>= 60,000/Ul
  7. * Serum creatinine =\< 1.5 mg/dL
  8. * Distant metastatic disease of peritoneum may be visualized on imaging:
  9. * Positive peritoneal cytology
  10. * Limited carcinomatosis on diagnostic laparoscopy or laparotomy
  11. * KRASD assay positive peritoneal washings/cytology
  12. * 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 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or metabolic response on positron emission tomography (PET)-magnetic resonance imaging (MRI) defined by PET Response Criteria in Solid Tumors (PERCIST) criteria
  13. * Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeons deems high likelihood for a complete cytoreduction
  1. * Distant metastatic disease not limited to peritoneum:
  2. * Solid organ metastases (liver, central nervous system, lung)
  3. * Infections such as pneumonia or wound infections that would preclude protocol therapy
  4. * 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
  5. * Subjects deemed unable to comply with study and/or follow-up procedures
  6. * 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

Contacts and Locations

Principal Investigator

Cornelius A. Thiels, D.O., M.B.A.
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Cornelius A. Thiels, D.O., M.B.A., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-01-05
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Pancreatic Carcinoma
  • Stage IV Pancreatic Cancer AJCC v8
  • Metastatic Malignant Neoplasm in the Peritoneum