Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Institut du Cancer de Montpellier - Val d'Aurelle (Voir sur ClinicalTrials)
octobre 2021
octobre 2031
14 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Eric BAUDIN | 16/02/2024 11:46:10 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Beaujon | Louis DE MESTIER, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Florence TENENBAUM, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Danielle BENISVY, MD | Contact (sur clinicalTrials) | |||
| Centre François Baclesse - 14076 - Caen - France | Elisabeth QAUK, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - 76000 - Rouen - France | David TONNELET, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - 63011 - Clermont-Ferrand - France | Anthony KELLY, MD | Contact (sur clinicalTrials) | |||
| Centre léon bérard - 69008 - Lyon - France | Anne-Laure GIRAUDET, MD | Contact (sur clinicalTrials) | |||
| CH Métropole de Savoie - 73011 - Chambéry - France | Jean-Cyril BOURRE, MD | Contact (sur clinicalTrials) | |||
| CHRU Lille - 59000 - Lille - France | Amandine BERON, PR | Contact (sur clinicalTrials) | |||
| CHRU Morvan - 29200 - Brest - France | Jean-Phillipe METGES, MD | Contact (sur clinicalTrials) | |||
| CHRU Nancy Brabois - 54511 - Vandœuvre-lès-Nancy - France | Elodie CHEVALIER, MD | Contact (sur clinicalTrials) | |||
| CHU de DIJON - 21079 - Dijon - France | Côme LEPAGE, MD | Contact (sur clinicalTrials) | |||
| CHU de Rouen - 76031 - Rouen - France | Frédéric Di FIORE, MD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes (CHUGA) - 38700 - La Tronche - France | Julie ROUX, MD | Contact (sur clinicalTrials) | |||
| CHU Nantes - 44093 - Nantes - France | Catherine ANSQUER, MD | Contact (sur clinicalTrials) | |||
| CHU ST Etienne - 42055 - Saint-Étienne - France | Vincent HABOUZIT, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone - 13385 - Marseille - France | David TAIEB, PR | Contact (sur clinicalTrials) | |||
| Hôpital Haut-Lévêque - 33604 - Pessac - France | Ghoufrane TLILI, MD | Contact (sur clinicalTrials) | |||
| Hôpital Pitié Salpétrière - 75013 - Paris - France | Charlotte LUSSEY, MD | Contact (sur clinicalTrials) | |||
| Hospices civils de LYON - GHE - 69677 - Bron - France | Solène CASTELLNOU, MD | Contact (sur clinicalTrials) | |||
| ICM Val d'Aurelle - 34298 - Montpellier - France | Emmanuel DESHAYES, MD | Contact (sur clinicalTrials) | |||
| Institut Bergonié - 33000 - Bordeaux - France | Paul SCHWARTZ, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44805 - Saint-Herblain - France | Hélène SENELLART, MD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest Site d'Angers - 49055 - Angers - France | Sylvie GIRAUD, MD | Contact (sur clinicalTrials) | |||
| Institut de cancérologie Strasbourg - 67033 - Strasbourg - France | Alessio IMPERIALE, PhD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13009 - Marseille - France | Nathalie CHARRIER, MD | Contact (sur clinicalTrials) | |||
| IUCT Oncopole - 31100 - Toulouse - France | Lawrence DIERICKX, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.