Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
NCT ID: NCT05987176
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2024-08-02
2025-10-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lutathera in People With Gastroenteropancreatic (GEP), Bronchial or Unknown Primary Neuroendocrine Tumors That Have Spread to the Liver
NCT04544098
Post-Authorization Long-Term Safety Study of LUTATHERA
NCT03691064
Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
NCT03972488
A Post Marketing Surveillance on Lutathera® in Patients With Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumor in Korea
NCT04946305
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
NCT04852679
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The control arm will consist of standard of 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.
In the treatment arm 177Lu-DOTATATE will be applied. The first cycle will be applied 6±2 weeks after liver resection. The frequency of administration will be 2 cycles (8±1weeks between each cycle). The rationale for 2 cycles in the adjuvant setting instead of 4 (as per standard protocol in palliative setting), assumes that after the removal of the primary tumour and the liver metastases, there will be no macroscopic residual tumour. Thus, the treatment dose should be sufficient to target microscopic disease and have the smallest possible effect on healthy tissue.
In the treatment arm, the patients will have 10 study visits for post -PRRT monitoring (blood tests and clinical assessments). Patients in the standard of care arm will have visits every 3 months. In both arms, patients will have one screening visit and one end of study visit. They will complete QoL questionnaires at baseline and at follow-up visits at 12, 24, and 36 months and bloods/urine will be collected for translational research prior to surgery (while in hospital) and at 6, 12, and 36 months.
Signature of informed consent precedes all study-specific assessments. All patients will have a fresh tumour sample collected during the liver surgery. Disease recurrence will be measured in all patients using liver MRIs every 3 months for the first year and every 6 months for the second to third year and 68Ga DOTA-TATE PET CT every 12 months for 3 years. Any patient with disease recurrence ceases treatment and assessments and will proceed to standard of care treatment for recurrent liver metastases.
Follow-up data will be collected for 5 years overall from the date of randomisation of the last patient.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care - Arm A
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
No interventions assigned to this group
Treatment - Arm B
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.
Lutathera
Dosage:
In total 14.8 GBq (400 mCi) 177Lu-DOTATATE administered in two equally divided doses. Each dose to be infused over 30 minutes.
Duration of treatment:
Two administrations of 177Lu-DOTATATE (each treatment 7.4 GBQ (200 mCi) at 8±1-week intervals, which can be extended to 16 weeks for resolving acute toxicity.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lutathera
Dosage:
In total 14.8 GBq (400 mCi) 177Lu-DOTATATE administered in two equally divided doses. Each dose to be infused over 30 minutes.
Duration of treatment:
Two administrations of 177Lu-DOTATATE (each treatment 7.4 GBQ (200 mCi) at 8±1-week intervals, which can be extended to 16 weeks for resolving acute toxicity.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Taylor Family 2010 Charitable Trust
UNKNOWN
Novartis/AAA
UNKNOWN
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea Frilling, Prof
Role: STUDY_CHAIR
Imperial College London
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-003575-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AF-ICL 01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.