Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver
Pancreatic Neuroendocrine Tumor, Pancreas Cancer
About this trial
This is an interventional treatment trial for Pancreatic Neuroendocrine Tumor focused on measuring pancreatic cancer, pancreas cancer
Eligibility Criteria
Inclusion Criteria: Metastatic Pancreatic neuroendocrine tumors (PanNET) to the liver Well- or moderately differentiated (grade 1 or grade 2, Ki- Ability to aim for equal or greater than 90% hepatic cytoreduction surgically Proof of SSTR2 expression by uptake of tumor on 68Ga DOTATATE PET CT (Krenning Score on all or a majority of lesions Age older than 18 years No history of chemotherapy for 4 weeks prior to enrollment (both patients with stable disease as well as those with tumor progression under other therapies will be enrolled). Exclusion Criteria: Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%) Previous liver-directed therapy with Yttrium-90/TACE/TAE Previous systemic therapy with Capecitabine and/or Temozolomide No tumor uptake on 68Ga DOTATATE PET CT Liver tumor burden > 50% (as defined by CT or MRI) Signs of early liver failure (T-Bilirubin >3, INR > 1.5, Albumin <3.0 g/dL unless prothrombin time is within the normal range) or cirrhosis or ascites calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as - confirmatory exam). 2. Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L - (75x103/mm3). Known brain metastases, unless these metastases have been treated and stabilized. Uncontrolled congestive heart failure (NYHA II, III, IV). Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN. Pregnancy or lactation. For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel). - Prior external beam radiation therapy to more than 25% of the bone marrow. Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP. Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence. Patients who have not provided a signed informed consent form to accept this treatment. Poor renal function
Sites / Locations
- The University of Chicago Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Arm 1- Control Arm - Standard Of Care - no peptide receptor radionuclide therapy
Arm 2 (peptide receptor radionuclide therapy + cytoreductive surgery)
Arm 1 is the control arm, which will undergo standard of care cytoreductive surgery (for the tumor). Participants in this arm will not receive peptide receptor radionuclide therapy (PRRT).
Arm 2 will undergo four cycles of peptide receptor radionuclide therapy (PRRT) before cytoreductive surgery.