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

Study Purpose

An international multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best supportive care in patients after resection of neuroendocrine liver metastases.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05987176
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors

Arms & Interventions

Arms

No Intervention: Standard of Care

Control arm as per standard of care patients go on routine follow up post surgery.

Experimental: Treatment

Treatment with Lutathera post surgery.

Interventions

Drug: - 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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chynna Pascual

[email protected]

02033133170

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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