Clinical trial · Interventional
Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
An International Multicentre Randomized Unblinded Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has closed earlier than planned due to one of the funders decision to withdraw the financial support for the study.
Summary
Brief summary (as posted)
An international multi-centre, open, randomised, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best supportive care in patients after complete surgical removal of neuroendocrine liver metastases. In this study, adjuvant treatment with 177Lu-DOTATATE will be compared with best supportive care in patients with well differentiated grade 1 or 2 neuroendocrine tumours in the stomach, pancreas or gut (gastro-entero-pancreatic NETs) who had their primary tumour already removed or in whom both primary and liver tumour metastases removal will take place simultaneously, including removal of perihilar lymph nodes will be eligible. The primary objective is to compare overall disease-free survival at 3 years after treatment with 177Lu-DOTATATE to best supportive care between both treatment arms, with equal chances of entering either arm (1:1) Secondary objectives are to describe and compare the difference in disease-free survival in the liver, overall survival, time to the next anticancer treatment, the cost effectiveness and health-related quality of life. The safety and toxicity of 177Lu-DOTATATE as adjuvant therapy will also be described. Additionally, the clinical use of blood and urine analysis test (NETest) will be evaluated to identify microscopic remaining disease and detect early the return of the tumour.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Neoplasm | Digestive System Neuroendocrine Neoplasm | ALIAS | 0.90 |
| Gastroenteropancreatic Neuroendocrine Tumor | Digestive System Neuroendocrine Tumor | ALIAS | 0.90 |
| Liver Metastases | — | UNRESOLVED | — |
| Neuroendocrine Tumor G1 (NET G1)/Carcinoid | — | UNRESOLVED | — |
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutathera | Drug | Lutetium (177lu) Oxodotreotide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care - Arm A
- description
- Control arm as per standard of care patients go on routine follow up post surgery. The control arm will consist of best supportive care. The study will be embedded within the regular clinical pathway for treatment and follow-up of patients with resectable NE LM. The follow-up will be according to current guidelines (e.g., Guidelines of the European Neuroendocrine Tumor Society for the management of advanced intestinal NET and pancreatic NET with locoregional and/or distant metastases). Patients will be followed up in the study for 3 years according to standard post-surgical follow-up protocol and thereafter in their local institution life-long according to follow-up after liver resection for NE LM
- type
- EXPERIMENTAL
- label
- Treatment - Arm B
- description
- Treatment with Lutathera post surgery. In the treatment arm 177Lu-DOTATATE will be applied. The frequency of administration will be 2 cycles (8±1weeks between each cycle). The rationale for 2 cycles instead of 4 (as per standard protocol in palliative setting), assumes that there will be no macroscopic residual tumour after liver resection. Thus, the treatment dose should be sufficient to target microscopic disease, and at the same time have smallest possible effect on healthy tissue.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent prior to any study related procedures 2. Patients aged 18 years or older 3. ECOG / WHO performance status 0 or 1 4. 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 5. 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 6. Patients with a primary tumour already resected or in whom the primary tumour has been resected synchronously with liver metastases 7. 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) 8. 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) Exclusion Criteria: 1. Less than 4 weeks post-surgery, or any other medical treatment, including chemotherapy, radiotherapy, and intrahepatic therapy 2. High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma \[NEC\]) 3. After R2 (tumour debulking, macroscopically incomplete resection) resection of neuroendocrine liver metastases 4. Patients with non-resectable neuroendocrine liver metastases and/or non-resectable primary tumour and /or non-resectable perihilar lymph node metastases 5. Pregnancy 6. 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) 7. Patients who have received prior systemic and/or liver-directed treatment for their metastatic NET other than somatostatin analogues 8. Hb concentration \<5.0 mmol/L (\<8.0 g/dL) 9. WBC \<2x109/L (2000/mm3) 10. Platelets \<75x109/L (75x103/mm3). 11. Total bilirubin \>3 x ULN. 12. Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. 13. Uncontrolled congestive heart failure (NYHA II, III, IV). 14. Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN. 15. Prior external beam radiation therapy to more than 25% of the bone marrow. 16. Kidney failure with serum creatinine \>150 µmol/L (\>1.7 mg/dL) 17. Known hypersensitivity to somatostatin analogues
References
Publications (0)
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