Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pancreatic Cancer and Peritoneal Metastasis
NCT ID: NCT04858009
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2024-02-15
2027-05-31
Brief Summary
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Detailed Description
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I. To evaluate overall survival and disease-free survival outcomes for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
SECONDARY OBJECTIVE:
I. To assess morbidity for patients with pancreatic adenocarcinoma with limited low volume peritoneal metastasis or positive peritoneal cytology undergoing hyperthermic intraperitoneal chemotherapy.
OUTLINE:
Patients undergo HIPEC with nab-paclitaxel and cisplatin over 90 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) during screening.
After completion of study treatment, patients are followed up every 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (HIPEC)
Patients undergo HIPEC with nab-paclitaxel and cisplatin over 90 minutes in the absence of disease progression or unacceptable toxicity. Patients may undergo additional HIPEC with paclitaxel and cisplatin up to 5 times. Patients undergo CT scan, MRI or PET during screening.
Cisplatin
Given via HIPEC
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC with mitomycin and cisplatin
Nab-paclitaxel
Given via HIPEC
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET scan
Interventions
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Cisplatin
Given via HIPEC
Hyperthermic Intraperitoneal Chemotherapy
Undergo HIPEC with mitomycin and cisplatin
Nab-paclitaxel
Given via HIPEC
Computed Tomography
Undergo CT scan
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Cornelius A. Thiels
Principal Investigator
Principal Investigators
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Cornelius A. Thiels, DO, MBA
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Summer L. Auerbach
Role: backup
Cornelius A. Thiels, DO, MBA
Role: backup
Travis E. Grotz, MD
Role: backup
Mark J. Truty, MD, MS
Role: backup
References
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Gudmundsdottir H, Yonkus JA, Thiels CA, Warner SG, Cleary SP, Kendrick ML, Truty MJ, Grotz TE. Oncologic Outcomes of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Highly Selected Patients with Metastatic Pancreatic Ductal Adenocarcinoma. Ann Surg Oncol. 2023 Nov;30(12):7833-7839. doi: 10.1245/s10434-023-14138-3. Epub 2023 Aug 19.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-02990
Identifier Type: REGISTRY
Identifier Source: secondary_id
18-009451
Identifier Type: -
Identifier Source: org_study_id