RecruitingPhase 2NCT04954820

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

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


Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

146 participants

Start Date

Oct 18, 2021

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lutathera for people with intestinal well differentiated endocrine tumor, neuroendocrine tumors, and other related conditions. The study is currently recruiting participants at 28 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutathera

2 additional infusions of Lutathera®


Locations(28)

Institut de Cancérologie de l'Ouest Site d'Angers

Angers, France

Institut Bergonié

Bordeaux, France

CHRU Morvan

Brest, France

Hospices civils de LYON - GHE

Bron, France

Centre François Baclesse

Caen, France

CH Métropole de Savoie

Chambéry, France

Centre Jean Perrin

Clermont-Ferrand, France

Hopital Beaujon

Clichy, France

CHU de DIJON

Dijon, France

CHU Grenoble Alpes (CHUGA)

La Tronche, France

CHRU Lille

Lille, France

Centre léon bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Hôpital de la Timone

Marseille, France

ICM Val d'Aurelle

Montpellier, France

CHU Nantes

Nantes, France

Centre Antoine Lacassagne

Nice, France

Hôpital Pitié Salpétrière

Paris, France

Hôpital Cochin

Paris, France

Hôpital Haut-Lévêque

Pessac, France

Centre Henri Becquerel

Rouen, France

CHU de Rouen

Rouen, France

CHU ST Etienne

Saint-Etienne, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, France

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

IUCT Oncopole

Toulouse, France

CHRU Nancy Brabois

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

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NCT04954820


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