Stage IV Pancreatic Cancer AJCC v8 Clinical Trial
Official title:
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Pancreatic Cancer and Peritoneal Metastasis
Verified date | January 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | May 2026 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Overall survival will be assessed from the date of cytoreduction and hyperthermic intraperitoneal chemotherapy (HIPEC) to death by any cause, regardless of disease recurrence. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing. | Up to 4 years | |
Primary | Progression-free survival | Progression-free survival is will be assessed from the date of cytoreduction and HIPEC to recurrence of tumor or death. Patterns of tumor recurrence and survival will be assessed by reviewing routine surveillance imaging. Patient may be contacted by telephone and/or videoconferencing. | Up to 4 years | |
Secondary | Morbidity | Morbidity is the state of having a specific illness or condition. Morbidity will be measured based on hospital length of stay, readmission rate, reoperation rate, and 30-day mortality (death). | 30 days; up to 4 years |
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