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Can more lutathera stop tumor progression? new study seeks answers

NCT ID NCT04954820

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is for people with intestinal neuroendocrine tumors that have started growing again after initial treatment with Lutathera. It compares giving two more cycles of Lutathera versus simply monitoring the tumor over six months. The goal is to see if extra treatment can better control the disease. About 146 adults will take part.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 146 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥ 18 years, * Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET), * Patient previously treated with 4 cycles of Lutathera® (defined as "First PRRT"), * Disease control after "First PRRT" ≥ 12 months, * Patient presenting a progression of disease (clinic, biologic and/or radiologic) after a first PRRT, * Decision of retreatment with Lutathera® (defined as "Second PRRT") validated by RENATEN and/or multidisciplinary tumor board and in the scope of the French reimbursement process, * ECOG performance status 0-2, * Life expectancy ≥ 6 months as prognosticated by the physician, * Somatostatin receptor imaging positive imaging (SSTRi+) disease within 4 months prior to inclusion : (may be PET imaging (68Ga-based SSTR analogues) or scintigraphy imaging: 111In-pentetreotide or 99mTc-octreotide. At least 90% of lesions must be positive for SSTRi with a significant uptake (\>= liver of surrounding tissue), * Measurable disease per RECIST 1.1 (Appendix 1), on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter, and ≥ 2 radiological tumors lesions in total, * Adequate bone marrow reserve (Hb \> 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³), * Negative pregnancy test in women of childbearing potential (the β-HCG dosage must be ≤ 4 days before inclusion). Women who have no reproductive potential are postmenopausal women or women who have had permanent sterilization, eg. tubal occlusion, hysterectomy, bilateral salpingectomy), * Effective contraception in men or women of childbearing or pre-menopausal age and up to a minimum of 6 months following the end of treatment, * Patient´s signed written informed consent, * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures, * Affiliation to the French Social Security System Exclusion Criteria: * Patient who did not respond (no CR, PR or SD) to "first PRRT". * Radiological progression after two cycles of "Second PRRT" according to RECIST version 1.1, * Grade 4 hematotoxicity and/or nephrotoxicity during the initial PRRT, or unresolved AEs categorized as Grade 2 or higher (as per Common Terminology Criteria for Adverse Events (CTCAE v5.0) from previous PRRT cycles or any other therapy for NET, excluding alopecia and peripheral neuropathy, * Pancreatic NET, * NeuroEndocrine Carcinoma, * Prior external beam radiation therapy to more than 25% of the bone marrow, * Severe renal (estimated Glomerular Filtration Rate (GFR) according to Modification of Diet in Renal Disease (MDRD) \< 40 mL/min or nephrotic syndrome) or hepatic insufficiency (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2.5 x ULN or ALT/AST \> 5 x ULN if liver function abnormalities are due to the underlying malignancy and/or total serum bilirubin \> 2.5 x ULN), * Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range, * Uncontrolled diabetes mellitus as defined by a fasting blood glucose above 2 ULN, * Uncontrolled decompensated heart failure, myocardial infarction uncontrolled, stroke, pulmonary embolism or revascularization procedure, unstable angina pectoris, uncontrolled cardiac arrhythmia, and clinically significant bradycardia during the last 12 months, * Hypertension that cannot be controlled despite medications (≥ 160/95 mmHg despite optimal medical therapy) * Brain metastases (unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrolment in the study. Patients with a history of brain metastases must have a head CT scan with contrast or MRI to document stable disease prior to enrolment in the study), * Pregnancy or breast feeding, * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results, * Known hypersensitivity to any of the study drugs, study drug classes, or any constituent of the products, * Concomitant participation or participation within the last 30 days in another clinical trial, * History of other solid tumor in 5 years before the inclusion excepted of cancer in situ of the cervix and skin cancer (basal or squamous cell) treated and controlled. * Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

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Conditions

The condition(s) this trial relates to.

Disease Progression intestinal neuroendocrine tumor G1 neuroendocrine neoplasm small intestine neuroendocrine tumor, well differentiated, low or intermediate grade

As listed by the trial registrant

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

Intestinal well differentiated endocrine tumor Neuroendocrine tumors Progressive disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Métropole de Savoie

    RECRUITING

    Chambéry, 73011, France

  • CHRU Lille

    RECRUITING

    Lille, 59000, France

  • CHRU Morvan

    RECRUITING

    Brest, 29200, France

  • CHRU Nancy Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • CHU Grenoble Alpes (CHUGA)

    RECRUITING

    La Tronche, 38700, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • CHU ST Etienne

    RECRUITING

    Saint-Etienne, 42055, France

  • CHU de DIJON

    RECRUITING

    Dijon, 21079, France

  • CHU de Rouen

    NOT_YET_RECRUITING

    Rouen, 76031, France

  • Centre Antoine Lacassagne

    RECRUITING

    Nice, 06189, France

  • Centre François Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76000, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, 63011, France

  • Centre léon bérard

    RECRUITING

    Lyon, 69008, France

  • Hopital Beaujon

    RECRUITING

    Clichy, 92110, France

  • Hospices civils de LYON - GHE

    RECRUITING

    Bron, 69677, France

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33604, France

  • Hôpital Pitié Salpétrière

    RECRUITING

    Paris, 75013, France

  • Hôpital de la Timone

    RECRUITING

    Marseille, 13385, France

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67091, France

  • ICM Val d'Aurelle

    RECRUITING

    Montpellier, 34298, France

  • IUCT Oncopole

    RECRUITING

    Toulouse, 31100, France

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33000, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, 13009, France

  • Institut de Cancérologie de l'Ouest

    RECRUITING

    Saint-Herblain, 44805, France

  • Institut de Cancérologie de l'Ouest Site d'Angers

    RECRUITING

    Angers, 49055, France

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