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Neuroendocrine TumorsPhase 2ReLUTHNCT04954820

Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET

A Phase 2 study testing Lutathera in people with Neuroendocrine Tumors and Intestinal Well Differentiated Endocrine Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle at 28 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lutathera
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
28 sitesFrance
Study dates
18 Oct 2021to Oct 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 16Show fewer
  • 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

Who cannot join

  • 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,
Show all 18Show fewer
  • 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.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Moussion Aurore, MD contact

+33467612446 ext. +33

aurore.moussion@icm.unicancer.fr

Texier Emmanuelle contact

0467613102

emmanuelle.texier@icm.unicancer.fr

28 sites in 1 country

France28 sites, 28 recruiting

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

    Angers, 49055

    Sylvie GIRAUD, MD, sylvie.girault@ico.unicancer.fr

    Recruiting

  • Institut Bergonié

    Bordeaux, 33000

    Paul SCHWARTZ, MD, p.schwartz@bordeaux.unicancer.fr

    Recruiting

  • CHRU Morvan

    Brest, 29200

    Jean-Phillipe METGES, MD, jean-philippe.metges@chu-brest.fr

    Recruiting

  • Hospices civils de LYON - GHE

    Bron, 69677

    Solène CASTELLNOU, MD, solene.castellnou@chu-lyon.fr

    Recruiting

  • Centre François Baclesse

    Caen, 14076

    Elisabeth QUAK, MD, e.quak@baclesse.unicancer.fr

    Recruiting

  • CH Métropole de Savoie

    Chambéry, 73011

    Jean-Cyril BOURRE, MD, jeancyril.bourre@ch-metropole-savoie.fr

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Anthony KELLY, MD, Antony.KELLY@clermont.unicancer.fr

    Recruiting

  • Hopital Beaujon

    Clichy, 92110

    Louis DE MESTIER, MD, louis.demestier@aphp.fr

    Recruiting

  • CHU de DIJON

    Dijon, 21079

    Côme LEPAGE, MD, come.lepage@u-bourgogne.fr

    Recruiting

  • CHU Grenoble Alpes (CHUGA)

    La Tronche, 38700

    Julie ROUX, MD, jroux@chu-grenoble.fr

    Recruiting

  • CHRU Lille

    Lille, 59000

    Amandine BERON, PR, Amandine.beron@chru-lille.fr

    Recruiting

  • Centre léon bérard

    Lyon, 69008

    Anne-Laure GIRAUDET, MD, anneLaure.giraudet@lyon.unicancer.fr

    Recruiting

  • Institut Paoli Calmettes

    Marseille, 13009

    Nathalie CHARRIER, MD, charriern@ipc.unicancer.fr

    Recruiting

  • Hôpital de la Timone

    Marseille, 13385

    David TAIEB, PR, david.taieb@ap-hm.fr

    Recruiting

  • ICM Val d'Aurelle

    Montpellier, 34298

    Emmanuel DESHAYES, MD, emmanuel.deshayes@icm.unicancer.fr

    Recruiting

  • CHU Nantes

    Nantes, 44093

    Catherine ANSQUER, MD, catherine.ansquer@chu-nantes.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Danielle BENISVY, MD, danielle.benisvy@nice.unicancer.fr

    Recruiting

  • Hôpital Pitié Salpétrière

    Paris, 75013

    Charlotte LUSSEY, MD, charlotte.lussey@aphp.fr

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Florence TENENBAUM, MD, florence.tenenbaum@aphp.fr

    Recruiting

  • Hôpital Haut-Lévêque

    Pessac, 33604

    Ghoufrane TLILI, MD, ghoufrane.tlili@chu-bordeaux.fr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76000

    David TONNELET, MD, david.tonnelet@chb.unicancer.fr

    Recruiting

  • CHU de Rouen

    Rouen, 76031

    Frédéric Di FIORE, MD, frederic.di-fiore@chu-rouen.fr

    Not yet recruiting

  • CHU ST Etienne

    Saint-Etienne, 42055

    Vincent HABOUZIT, MD, vincent.habouzit@chu-st-etienne.fr

    Recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

    Hélène SENELLART, MD, helene.senellart@ico.unicancer.fr

    Recruiting

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

    Alessio IMPERIALE, PhD, alessio.imperiale@chru-strasbourg.fr

    Recruiting

  • IUCT Oncopole

    Toulouse, 31100

    Lawrence DIERICKX, MD, dierickx.lawrence@iuct-oncopole.fr

    Recruiting

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, 54511

    Elodie CHEVALIER, MD, e.chevalier@chru-nancy.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Eric BAUDIN, MD, eric.baudin@gustaveroussy.fr

    Recruiting

Other trials in France

About this study

Official title: A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera® ([177LU]LU-DOTA-TATE) in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor

In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.

Read the detailed description

The NETTER-1 clinical trial compared peptide receptor radionuclide therapy (PRRT) with [177Lu]Lu-DOTA-TATE (Lutathera®) every eight weeks (4 doses) plus 30 mg octreotide LAR every 4 weeks with high dose (60 mg) of octreotide LAR every 4 weeks in patients with progressive and unresectable midgut neuroendocrine well differentiated (G1, G2) tumors (NETs) with somatostatin-receptor positive imaging (SSTRi+). Lutathera® improves both median progression free survival (PFS) (28.4 months vs 8.5 months) and median overall survival (OS) ("not reached" vs 27.4 months) with a follow-up of 42 months. Lutathera® also has an impact on quality of life. Therefore, this treatment was approved by the European Medicines Agency and is now reimbursed in France in that specific indication. Despite these promising results, progression will occur in most of patients within a variable time with limited treatment options left. Retreatment with additional cycles of Lutathera® may be an option. Van der Zwan et al. showed in a large retrospective cohort (the "ROTTERDAM cohort") a median PFS of 14.6 months after retreatment with two additional cycles of PRRT with [177Lu]Lu-DOTA-TATE and a significant longer OS than in the non-randomized control group. Interestingly, the safety was similar in salvage group than in initial PRRT: no grade (G) 3/4 renal toxicity occurred and hematological toxicities were similar to the group of patients who received the initial treatment (4 cycles). In a smaller cohort of 15 patients, Yordanova et al. showed that 8 or more cycles of [177Lu]Lu-DOTA-TATE were well tolerated and led to a survival improvement. In this study, each salvage therapy consisted of 2 or 3 cycles. No severe (G3, G4) renal toxicity or G4 adverse event occurred. In France, since the reimbursement of Lutathera®, this treatment is allowed for retreatment if patients still fulfill the criteria of its indication and 4 news cycles could be proposed. However, clinical practices are heterogeneous regarding the number of new cycles and most teams perform only two additional cycles (every 8 weeks). Therefore, the coordinator propose to evaluate the efficacy of two additional cycle of Lutathera® versus active surveillance in patients already retreated with two cycles Lutathera® for a new progression of intestinal neuroendocrine tumor and who previously received the 4 cycles of treatment with a clinical benefit.

Being tested
Lutathera
Medical subject headings
Neuroendocrine Tumors, Disease Progression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutatheraDrug

    2 additional infusions of Lutathera®

Study groups in NCT04954820
Study groupRoleWhat they receive
Experimental armExperimental2 additional infusions of Lutathera® according to the marketing authorization schema
Receives: Drug: Lutathera
Control armNo interventionNo treatment with active monitoring (clinical, biological and radiological follow-up) every 2 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles.

    defined as a change of tumoral assessment (Complete Response, Partial Response and Stable Disease from RECIST v1.1) with an evaluation every 2 months.

    Measured: assessement every cycle (every 8 weeks) 6 months from randomization

Secondary outcomes (5)

  1. Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Safety

    Number and type of adverse event according to NCI-CTCAE v5.0.

    Measured: during 6 months in patients already retreated with two cycles (each cycle is 8 weeks)

  2. Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Progression free survival

    the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first

    Measured: the time without progression of disease during 5 years after the treatment,

  3. Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Overall survival

    the time from randomization until death from any cause.

    Measured: the time without death during 5 years after the treatment

  4. To assess quality of life of general patient

    Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality-of-life questionnaire C30, no min and max values)

    Measured: during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment

  5. To assess quality of life of gastrointestinal neuroendocrine tumor

    Quality of life will be measured by EORTC GI.NET21 questionnaire (European Organisation for Research and Treatment of Cancer, gastrointestinal neuroendocrine tumor, no min and max values)

    Measured: during and after treatment in both arm : every 8 wweks during the treatment, every 3 months during 1 year post treatment and every year during 4 years post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2021
  2. Study start18 Oct 2021
  3. Primary completionOct 2033 (estimated)
  4. Study completionOct 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
It's a prospective, national, multicenter, open-label, randomized, phase II study, to compare 2 additional cycles of Lutathera® versus active surveillance in patients who already received two cycles of "Second PRRT" (already retreated with two cycles). Written informed consent will be collected before any study related procedures take place. Patients previously treated with 4 cycles of Lutathera® will be registered after a first progression (clinic, biologic and/or radiologic) of their neuroendocrine tumor.
Masking
None (open label)
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04954820
Sponsor's protocol ID
PROICM 2021-04 REL
Acronym
ReLUTH
Status last verified
Jun 2026
First submitted
11 Jun 2021
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.

Publications

  • Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.

    PubMed 18565894

  • Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Oberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

    PubMed 28076709

  • Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

    PubMed 29878866

  • Rudisile S, Gosewisch A, Wenter V, Unterrainer M, Boning G, Gildehaus FJ, Fendler WP, Auernhammer CJ, Spitzweg C, Bartenstein P, Todica A, Ilhan H. Salvage PRRT with 177Lu-DOTA-octreotate in extensively pretreated patients with metastatic neuroendocrine tumor (NET): dosimetry, toxicity, efficacy, and survival. BMC Cancer. 2019 Aug 8;19(1):788. doi: 10.1186/s12885-019-6000-y.

    PubMed 31395036

  • Vaughan E, Machta J, Walker M, Toumpanakis C, Caplin M, Navalkissoor S. Retreatment with peptide receptor radionuclide therapy in patients with progressing neuroendocrine tumours: efficacy and prognostic factors for response. Br J Radiol. 2018 Nov;91(1091):20180041. doi: 10.1259/bjr.20180041. Epub 2018 Mar 20.

    PubMed 29513039

  • Yordanova A, Mayer K, Brossart P, Gonzalez-Carmona MA, Strassburg CP, Essler M, Ahmadzadehfar H. Safety of multiple repeated cycles of 177Lu-octreotate in patients with recurrent neuroendocrine tumour. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1207-1214. doi: 10.1007/s00259-017-3652-1. Epub 2017 Mar 1.

    PubMed 28246882

  • Sabet A, Haslerud T, Pape UF, Sabet A, Ahmadzadehfar H, Grunwald F, Guhlke S, Biersack HJ, Ezziddin S. Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2014 Feb;41(2):205-10. doi: 10.1007/s00259-013-2547-z. Epub 2013 Sep 13.

    PubMed 24030668

  • van Essen M, Krenning EP, Kam BL, de Herder WW, Feelders RA, Kwekkeboom DJ. Salvage therapy with (177)Lu-octreotate in patients with bronchial and gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2010 Mar;51(3):383-90. doi: 10.2967/jnumed.109.068957. Epub 2010 Feb 11.

    PubMed 20150247

  • Gleisner KS, Brolin G, Sundlov A, Mjekiqi E, Ostlund K, Tennvall J, Larsson E. Long-Term Retention of 177Lu/177mLu-DOTATATE in Patients Investigated by gamma-Spectrometry and gamma-Camera Imaging. J Nucl Med. 2015 Jul;56(7):976-84. doi: 10.2967/jnumed.115.155390. Epub 2015 May 21.

    PubMed 25999429

  • Sundlov A, Sjogreen-Gleisner K, Svensson J, Ljungberg M, Olsson T, Bernhardt P, Tennvall J. Individualised 177Lu-DOTATATE treatment of neuroendocrine tumours based on kidney dosimetry. Eur J Nucl Med Mol Imaging. 2017 Aug;44(9):1480-1489. doi: 10.1007/s00259-017-3678-4. Epub 2017 Mar 22.

    PubMed 28331954

  • Del Prete M, Buteau FA, Arsenault F, Saighi N, Bouchard LO, Beaulieu A, Beauregard JM. Personalized 177Lu-octreotate peptide receptor radionuclide therapy of neuroendocrine tumours: initial results from the P-PRRT trial. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):728-742. doi: 10.1007/s00259-018-4209-7. Epub 2018 Nov 30.

    PubMed 30506283

  • Deshayes E, Assenat E, Meignant L, Bardies M, Santoro L, Gourgou S. A prospective, randomized, phase II study to assess the schemas of retreatment with Lutathera(R) in patients with new progression of an intestinal, well-differentiated neuroendocrine tumor (ReLUTH). BMC Cancer. 2022 Dec 22;22(1):1346. doi: 10.1186/s12885-022-10443-4.

    PubMed 36550428

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutathera in people with Neuroendocrine Tumors and Intestinal Well Differentiated Endocrine Tumor, run by Institut du Cancer de Montpellier - Val d'Aurelle at 28 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Moussion Aurore, MD (+33467612446 ext. +33, aurore.moussion@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles. (time frame: assessement every cycle (every 8 weeks) 6 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04954820, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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