NELMAS - adjuvant treatment of patients after resection of neuroendocrine liver metastases
Research type
Research Study
Full title
NELMAS - A multi-centre, stratified, open, randomized, comparator-controlled, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE (Lutathera®) to best supportive care in patients after resection of neuroendocrine liver metastases.
IRAS ID
1006904
Contact name
Andrea Frilling
Contact email
Sponsor organisation
Imperial College London
Eudract number
2022-003575-42
Research summary
Surgery is the mainstay of treatment for patients with neuroendocrine liver metastases (NE LM). Not only does it have potential to improve survival but also to ameliorate clinical symptoms of hormonal excess. While complete resection for NE LM is associated with favourable 3-year, 5-year and 10-year survivals of 83%, 70%, and 42%, respectively, recurrence rates of 70% at <3 years and up to 94% at 5 years have been reported. These alarming results call for adjuvant treatment concepts which have not yet been established.
This is an international multicentre randomised phase II study comparing treatment with 177Lu-DOTATATE (Lutathera®) to best supportive care in patients after resection of neuroendocrine liver metastases. The aim of the study is to evaluate recurrence rate of the disease or death at 3-years from liver resection in the two trial groups.
After liver surgery patients will be allocated to treatment with 177Lu-DOTATATE (Lutathera®) or best supportive care. 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. Patients who are randomised to the treatment arm will receive 2 doses of 177Lu-DOTATATE (Lutathera®) before entering the follow-up phase. Patients who are randomised to best supportive care will enter follow-up straight away after liver surgery. The total number of patients entering the study will be 90 (45 per arm). This trial will be interwoven with translational research analysing the clinical utility of novel molecular biomarkers identifying residual disease and detecting early recurrence.
We postulate that treatment with 177Lu-DOTATATE (Lutathera®) will reduce the disease recurrence after resection of NE LM. We anticipate a change of practice for patients with neuroendocrine tumours should the study show an advantage for the use of the 177Lu-DOTATATE (Lutathera®).REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0293
Date of REC Opinion
15 Jan 2024
REC opinion
Further Information Favourable Opinion