A prospective, randomised, controlled, open-label, multicentre phase III study to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).
Phase 3
Recruiting
- Conditions
- Neuroendocrine tumor - NET10017991
- Registration Number
- NL-OMON52990
- Lead Sponsor
- ITM Solucin GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Written informed consent
2. Male or female >=18 years of age
3. Histologically and clinically confirmed diagnosis of well-differentiated
neuroendocrine tumour of non-functional gastroenteric origin (GE-NET) or both
functional or non-functional pancreatic origin P-NET), grade G1 or G2 (Ki-67 <
20%), unresectable or metastatic, in a patient who is either treatment-naïve
(1st line) or who has progressed under prior therapy (2nd line)
Exclusion Criteria
1. Known hypersensitivity to edotreotide or everolimus
2. Known hypersensitivity to DOTA, lutetium-177, or any excipient of
edotreotide or everolimus
3. Known hypersensitivity to lysin, arginin, or any excipient of the
nephroprotective amino acid solution
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is progression-free survival (PFS). Diagnosis of<br /><br>progression and liver tumour burden will be established based on<br /><br>radiological information from morphological imaging (MRI and/or CT) according<br /><br>to RECIST 1.1. Stratification will be made for primary tumour origin (GE-NET<br /><br>vs. P-NET) and prior medical therapy (1st line vs. 2nd line). Tumour grade (G1,<br /><br>G2), and baseline Karnofsky score will be used for further statistical subgroup<br /><br>analyses.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include parameters of morphological and biomarker tumour<br /><br>response such as objective response rate (ORR), overall survival<br /><br>(OS), disease control rates (DCR), as well as duration of disease control<br /><br>(DDC), safety, health-related quality of life (HRQL). Furthermore, exploratory<br /><br>analyses will be performed on patient and tumour characteristics, as well as<br /><br>the degree of 177Lu-edotreotide uptake for traits predicting PRRT efficacy.</p><br>