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Radioactive therapy vs. pill: which works better for gut and pancreas tumors?

NCT ID NCT03049189

Disease control Sponsor: ITM Solucin GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether a radioactive drug called 177Lu-Edotreotide (PRRT) works better than the daily pill everolimus for people with advanced neuroendocrine tumors of the gut or pancreas that can't be removed by surgery. About 324 participants are randomly assigned to receive either four cycles of PRRT or daily everolimus. The main goal is to see which treatment delays tumor growth longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
177Lu-Edotreotide (a radioactive drug) and Everolimus (a targeted therapy)
What this could lead to
If successful, this could provide a more effective treatment option for people with advanced neuroendocrine tumors that cannot be surgically removed.
What could go wrong
This is a late-stage trial, but results are not yet available. The radioactive treatment may cause side effects like kidney damage or low blood counts, and it may not prove better than the current standard everolimus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

324 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.).

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2 neuroendocrine neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neuroendocrine tumors

Contacts and locations

Locations

  • "Gammed" Izabela Chuchrowksa

    Warsaw, 02-351, Poland

  • Academic Medical Center, University of Amsterdam

    Amsterdam, 1100DD, Netherlands

  • Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Banner Health d.b.a. Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • CHU de Nantes - Hôtel Dieu

    Nantes, 44093, France

  • Central University Hospital de Asturias (HUCA)

    Oviedo, 33011, Spain

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • European Institute of Oncology (EIO)

    Milan, 20141, Italy

  • Excel Diagnostics & Nuclear Oncology Center

    Houston, Texas, 77042, United States

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • HP Hôpital Beaujon

    Clichy, 92110, France

  • Hospices civils de Lyon

    Bron, 69677, France

  • ICO Hospitalet, Granvia de l'Hospitalet

    Barcelona, 08909, Spain

  • IUCT-Oncopole

    Toulouse, 31059, France

  • Inselspital, Universitätsspital Bern

    Bern, 3010, Switzerland

  • Institut Jules Bordet

    Brussels, 1000, Belgium

  • Institut de Recherche en Cancérologie de Montpellier (IRCM)

    Montpellier, 34298, France

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl

    Meldola, 47014, Italy

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinikum rechts der Isar Technische Universität München

    Munich, 81675, Germany

  • MD Anderson Cancer Center Madrid

    Madrid, 28033, Spain

  • MSC Memorial Cancer Centre

    Gliwice, 44-100, Poland

  • Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Olivia Newton-John Cancer & Wellness Centre, Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Philipps Universität Marburg

    Marburg, 35043, Germany

  • Royal Free NHS Foundation Trust

    London, NW3 2QG, United Kingdom

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Stanford University

    Stanford, California, 94305, United States

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000, Belgium

  • University Cape Town (UCT), Groote Schuur Hospital

    Cape Town, 7925, South Africa

  • University Hospital 12 de Octubre

    Madrid, 28041, Spain

  • University Hospital Motol

    Prague, 150 06, Czechia

  • University Hospital Olomouc

    Olomouc, 775 20, Czechia

  • University Medical Center, Abteilung für Nuklearmedizin

    Hamburg, 20251, Germany

  • University and Polytechnic Hospital La Fe

    Valencia, 46026, Spain

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pretoria & Steve Biko Academic Hospital

    Pretoria, 0001, South Africa

  • UniversitätsSpital Zürich

    Zurich, 8091, Switzerland

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Magdeburg A.ö.R., Otto-von-Guericke Universität

    Magdeburg, 39120, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg

    Würzburg, 97080, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Vall d'Hebron University Hospital

    Barcelona, 08035, Spain

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437, Germany

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