NCT04858009 Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
| NCT ID | NCT04858009 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mayo Clinic |
| Condition | Metastatic Pancreatic Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-02-15 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Cornelius A. Thiels, DO, MBA
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT04858009 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metastatic Pancreatic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04858009 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04858009 currently recruiting?
Yes, NCT04858009 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT04858009 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04858009 clinical trial?
NCT04858009 is sponsored by Mayo Clinic. The principal investigator is Cornelius A. Thiels, DO, MBA at Mayo Clinic in Rochester. The trial plans to enroll 40 participants.