Actively Recruiting
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2026-02-05
146
Participants Needed
28
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3 18 years
- Histologically proven intestinal G1 or G2 neuroendocrine tumors (NET)
- Previously treated with 4 cycles of Lutathera4 ("First PRRT")
- Disease control after "First PRRT" for 12 months or more
- Presenting progression of disease after first PRRT
- Retreatment decision approved by RENATEN or multidisciplinary tumor board
- ECOG performance status between 0 and 2
- Life expectancy of 6 months or more
- Positive somatostatin receptor imaging within 4 months before inclusion
- Measurable disease per RECIST 1.1 with at least one lesion �3 1 cm and two or more tumor lesions
- Adequate bone marrow function (Hb > 8 g/dl, neutrophils �3 1500/mm3, platelets �3 80,000/mm3)
- Negative pregnancy test for women of childbearing potential
- Effective contraception for men and women of childbearing or pre-menopausal age during and 6 months post-treatment
- Signed informed consent
- Ability and willingness to follow study visits, treatment, and tests
- Affiliated with the French Social Security System
You will not qualify if you...
- Lack of response (no complete response, partial response, or stable disease) to first PRRT
- Radiological progression after two cycles of second PRRT
- Grade 4 hematotoxicity or nephrotoxicity during initial PRRT or unresolved grade 2 or higher adverse events from prior therapies
- Pancreatic neuroendocrine tumors
- Neuroendocrine carcinoma
- Prior radiation therapy to more than 25% of bone marrow
- Severe kidney or liver failure
- Low serum albumin unless normal prothrombin time
- Uncontrolled diabetes mellitus
- Uncontrolled severe heart conditions or recent serious cardiac events
- Uncontrolled high blood pressure despite medication
- Brain metastases unless treated and stable for at least 24 weeks
- Pregnancy or breastfeeding
- Substance abuse or medical/psychological/social conditions interfering with participation
- Known allergy to study drugs or components
- Participation in another clinical trial within the last 30 days
- History of other solid tumors within 5 years except controlled cervical or skin cancer
- Legal incapacity or conditions preventing informed consent or study completion
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Institut de Cancérologie de l'Ouest Site d'Angers
Angers, France, 49055
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33000
Actively Recruiting
3
CHRU Morvan
Brest, France, 29200
Actively Recruiting
4
Hospices civils de LYON - GHE
Bron, France, 69677
Actively Recruiting
5
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
6
CH Métropole de Savoie
Chambéry, France, 73011
Actively Recruiting
7
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
8
Hopital Beaujon
Clichy, France, 92110
Actively Recruiting
9
CHU de DIJON
Dijon, France, 21079
Actively Recruiting
10
CHU Grenoble Alpes (CHUGA)
La Tronche, France, 38700
Actively Recruiting
11
CHRU Lille
Lille, France, 59000
Actively Recruiting
12
Centre léon bérard
Lyon, France, 69008
Actively Recruiting
13
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
14
Hôpital de la Timone
Marseille, France, 13385
Actively Recruiting
15
ICM Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
16
CHU Nantes
Nantes, France, 44093
Actively Recruiting
17
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
18
Hôpital Pitié Salpétrière
Paris, France, 75013
Actively Recruiting
19
Hôpital Cochin
Paris, France, 75014
Actively Recruiting
20
Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
21
Centre Henri Becquerel
Rouen, France, 76000
Actively Recruiting
22
CHU de Rouen
Rouen, France, 76031
Not Yet Recruiting
23
CHU ST Etienne
Saint-Etienne, France, 42055
Actively Recruiting
24
Institut de Cancérologie de l'Ouest
Saint-Herblain, France, 44805
Actively Recruiting
25
Institut de cancérologie Strasbourg
Strasbourg, France, 67033
Actively Recruiting
26
IUCT Oncopole
Toulouse, France, 31100
Actively Recruiting
27
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
28
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
M
Moussion Aurore, MD
CONTACT
T
Texier Emmanuelle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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