Status:
RECRUITING
Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
Lead Sponsor:
Mayo Clinic
Conditions:
Metastatic Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 meta...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate overall survival and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal ...
Eligibility Criteria
Inclusion
- Age \>= 18 but =\< 80
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
- Cytologic or histologic proof of adenocarcinoma of the pancreas
- 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 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
- Peritoneal Carcinomatosis Index (PCI) =\< 7 and surgeons deems high likelihood for a complete cytoreduction
Exclusion
- 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
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04858009
Start Date
February 15 2024
End Date
July 1 2029
Last Update
December 16 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905