NCT05987176TerminatedPhase 2
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 · Last updated 14 Jan 2026
Reason given: The study has closed earlier than planned due to one of the funders decision to withdraw the financial support for the study.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 8 Mar 2023
- Start date
- 2 Aug 2024
- Primary completion date
- 21 Oct 2025
- Lead sponsor
- Imperial College London
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT05987176
- EudraCT number
- 2022-003575-42
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Uncontrolled congestive heart failure (NYHA II, III, IV).
- Known hypersensitivity to somatostatin analogues
Lab values
- 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)
Other
- 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)
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.