Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver

Korábbi kezelés

• Previous liver-directed therapy with Yttrium-90 (TACE/TAE allowed if performed more than 12 months prior to enrollment)
• Systemic therapy with Capecitabine and/or Temozolamide within 12 months of enrollment.
• 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.

Más betegség

• Uncontrolled congestive heart failure (NYHA II, III, IV).
• 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.

Laborértékek

• 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).
• Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.

Egyéb

• Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%)
• No tumor uptake on 68Ga DOTATATE PET CT
• Liver tumor burden > 50% (as defined by CT or MRI)
• Known brain metastases, unless these metastases have been treated and stabilized.
• Pregnancy or lactation.
• Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
• Patients who have not provided a signed informed consent form to accept this treatment.
• Poor renal function
• Quality Unit language added
• editorial changes

• 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 Somatostatin Analogues (SSA) or other systemic therapy for 4 weeks prior to starting PRRT, if randomized to arm 2.