TerminatedPhase 2

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

Stopped: The study has closed earlier than planned due to one of the funders decision to withdraw the financial support for the study.

United Kingdom1 participantsStarted 2024-08-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

What they're measuring

Disease free survival

Timeframe: 3 years

Trial details

NCT IDNCT05987176

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-21

View on ClinicalTrials.gov More Neuroendocrine Tumor G1 (NET G1)/Carcinoid trials