Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients
- Conditions
- Neuroendocrine Tumors
- Interventions
- Registration Number
- NCT03049189
- Lead Sponsor
- ITM Solucin GmbH
- Brief Summary
The purpose of the study is 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 309
- Histologically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
- Measurable disease per RECIST 1.1
- Somatostatin receptor positive (SSTR+) disease
- Progressive disease based on RECIST 1.1. criteria as evidenced by two morphological imaging examinations made with the same imaging method (either CT or MRI)
- Known hypersensitivity to edotreotide or everolimus
- Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus or any other Rapamycin derivative
- Prior exposure to any peptide receptor radionuclide therapy (PRRT)
- Prior therapy with mTor inhibitors
- Prior EFR (external field radiation) to GEP-NET lesions within 90 days before randomisation or radioembolisation therapy
- Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
- Indication for surgical lesion removal with curative potential
- Planned alternative therapy (for the period of study participation)
- Serious non-malignant disease
- Clinically relevant renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
- Pregnant or breast-feeding women
- Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g. persons institutionalised, incarcerated etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 177Lu-edotreotide PRRT Amino-Acid Solution 177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months) Everolimus Everolimus Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS) 177Lu-edotreotide PRRT 177Lu-edotreotide PRRT 177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)
- Primary Outcome Measures
Name Time Method progression-free survival (PFS) 12 weeks +/- 14 days, up to 30 months PFS will be assessed individually per patient from date of randomization until the date of first documented progression or death, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
- Secondary Outcome Measures
Name Time Method objective response rates (ORR) 12 weeks +/- 14 days, up to 30 months ORR will be assessed, defined as the proportion of patients achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus
overall survival (OS) 12 weeks +/- 14 days, up to 90 months OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death
Trial Locations
- Locations (52)
Banner Health d.b.a. Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Stanford University
🇺🇸Stanford, California, United States
Moffitt Cancer Center & Research Institute
🇺🇸Tampa, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Excel Diagnostics & Nuclear Oncology Center
🇺🇸Houston, Texas, United States
Royal North Shore Hospital
🇦🇺Saint Leonards, New South Wales, Australia
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
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