Current partner codePEPTIDESDE
NCT03049189·Phase 3·INTERVENTIONAL

Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients

Status

Active, not recruiting

Phase

Phase 3

Enrollment

324

Locations

52

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

177Lu-edotreotide PRRT

PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.

DRUG

Everolimus

Everolimus will be administered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.

OTHER

Amino-Acid Solution

The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT

Timeline

From registration to results.

  1. First posted

    Feb 9, 2017

  2. Study start

    Feb 2, 2017

  3. Primary completion

    Nov 27, 2024

  4. Study completion

    Nov 2029

  5. Results posted

    Apr 6, 2026

  6. Registry updated

    Apr 6, 2026

Outcomes

What the study measures.

Primary outcomes

Progression-Free Survival (PFS)

Time frame · From date of randomization until the date of first documented progression or death, assessed up to 30 months,

PFS determined as time elapsed between randomization, and the date of first objective report of tumor progression (evaluated by RECIST criteria v1.1) as evaluated by the Blinded Independent Central Review (BICR), or death.

Secondary outcomes

Objective Response Rate (ORR)

Time frame · Up to 30 months

ORR will be assessed, defined as the proportion of participants achieving partial response (PR) or complete response (CR) as best outcome, after treatment with 177Lu-edotreotide compared to everolimus.

Overall Survival (OS)

Time frame · Overall Survival (OS) will be followed up for 5 years (60 months) after the End of Study (EOS)

From the date of randomisation until the date of death up to the up to the end of the 5 year post-study follow-up.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 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) Exclusion Criteria: * 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 locations

52 registered sites.

Australia · Austria · Belgium · Czechia · France · Germany · Italy · Netherlands · Poland · South Africa · Spain · Switzerland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

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

Allgemeines Krankenhaus Wien

Vienna, Austria

Institut Jules Bordet

Brussels, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

University Hospital Olomouc

Olomouc, Czechia

University Hospital Motol

Prague, Czechia

Hospices civils de Lyon

Bron, France

Centre Jean Perrin

Clermont-Ferrand, France

HP Hôpital Beaujon

Clichy, France

Institut de Recherche en Cancérologie de Montpellier (IRCM)

Montpellier, France

CHU de Nantes - Hôtel Dieu

Nantes, France

IUCT-Oncopole

Toulouse, France

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Charité - Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Bonn

Bonn, Germany

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

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