Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases

Korábbi kezelés

• Less than 4 weeks post-surgery, or any other medical treatment, including chemotherapy, radiotherapy, and intrahepatic therapy
• After R2 (tumour debulking, macroscopically incomplete resection) resection of neuroendocrine liver metastases
• Patients who have received prior systemic and/or liver-directed treatment for their metastatic NET other than somatostatin analogues
• Prior external beam radiation therapy to more than 25% of the bone marrow.

Más betegség

• Uncontrolled congestive heart failure (NYHA II, III, IV).
• Known hypersensitivity to somatostatin analogues

Laborértékek

• Hb concentration <5.0 mmol/L (<8.0 g/dL)
• WBC <2x109/L (2000/mm3)
• Platelets <75x109/L (75x103/mm3).
• Total bilirubin >3 x ULN.
• Serum albumin <3.0 g/dL unless prothrombin time is within the normal range.
• Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.
• Kidney failure with serum creatinine >150 µmol/L (>1.7 mg/dL)

Egyéb

• High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma [NEC])
• Patients with non-resectable neuroendocrine liver metastases and/or non-resectable primary tumour and /or non-resectable perihilar lymph node metastases
• Pregnancy
• Subjects of childbearing potential (both male and female participants) not willing to use a combination of adequate contraceptive measures, e.g., oral contraceptives, IUD, barrier methods of contraception (condom or occlusive cap with spermicide)

• Written informed consent prior to any study related procedures
• Patients aged 18 years or older
• ECOG / WHO performance status 0 or 1
• Patients with well differentiated grade 1 or grade 2 (Ki67<20%) GEP NET confirmed by histological criteria with the primary localisation in stomach, pancreas, or gut
• Patients after R0 (complete macroscopic and microscopic resection) or R1 (complete macroscopic resection, microscopically positive resection margins) resection of neuroendocrine liver metastases confirmed by histological criteria
• Patients with a primary tumour already resected or in whom the primary tumour has been resected synchronously with liver metastases
• MRI scan prior to surgery (within 4 -6 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place)
• Somatostatin receptor-based imaging (68Ga DOTA-TATE PET/CT prior to surgery (within 12 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place)