Continuing Somatostatin Analogues Upon Progression in Neuroendocrine Tumour pAtients (SAUNA)
Gastroenteropancreatic Neuroendocrine Tumor
About this trial
This is an interventional treatment trial for Gastroenteropancreatic Neuroendocrine Tumor focused on measuring somatostatin analogues, neuroendocrine tumor
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Written informed consent prior to any study-related procedures Eastern Cooperative Oncology Group (ECOG) performance status ≤2, Histologically-proven diagnosis of locally advanced or metastatic, non-functional, well-differentiated World Health Organisation 2019 grade 1-2 GEP NET Documented radiological disease progression on first-line SSA treatment For targeted therapy substudy: indication to start with either sunitinib or everolimus as second-line therapy, according to local investigator For PRRT substudy: indication to start with PRRT with Lutetium (177Lu) oxodotreotide as second-line therapy, according to local investigator Exclusion Criteria: Indication for chemotherapy treatment of GEP NET in second-line Presence of poorly differentiated grade 3 neuroendocrine carcinoma (NEC), well-differentiated grade 3 NET or rapidly progressive NET Prior treatment with everolimus, sunitinib or PRRT Contra-indication, proven allergy or other indication than functional NET for the use of a SSA Patient showing progressive disease while being on a lower than the registered dose Functional NET, defined as the presence of clinical and biochemical evidence of a hormonal NET-related syndrome Patient undergoing palliative, systemic oncological treatment for other malignancy than GEP NET Concurrent anti-cancer treatment in another investigational trial Any abnormal findings at baseline, clinical finding, including psychiatric and behavioural problems, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study Pregnant or lactating patient at screening or if the patient wishes to get pregnant during treatment phase of the trial
Sites / Locations
- AZ Klina
- AZ Rivierenland
- Ghent University Hospital
- VITAZ
- University Hospital Leuven
- Grand Hôpital de Charleroi
- AZ Monica
- Ziekenhuis Netwerk Antwerpen
- GZA
- H.U.B.
- Cliniques Universitaires Saint-Luc
- Antwerp University HospitalRecruiting
- Centre Hospitalier Universitaire Sart Tilman
- AZ Voorkempen
- Rijstate
- Maastricht UMC+
- Maxima Medisch Centrum
- Amsterdam UMC
- UMC Groningen
- Erasmus MC
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
somatostatin analogs continuation
somatostatin analogs withdrawal
Somatostatin analog (octreotide long-acting release (LAR) 30 mg or lanreotide 120 mg) will be given every four weeks for a duration of 18 months.
Somatostatin analog treatment (octreotide LAR 30 mg or lanreotide 120 mg) will be withdrawn for a duration of 18 months.