OncoMatch/Clinical Trials/NCT04954820
Assessment of Retreatment With Lutathera® in Patients With New Progression of Intestinal Well-differenciated NET
Is NCT04954820 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutathera for neuroendocrine tumors.
Treatment: Lutathera — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroendocrine Tumor
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: peptide receptor radionuclide therapy (Lutathera) — 4 cycles (First PRRT)
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
Cannot have received: external beam radiation therapy
Exception: to more than 25% of the bone marrow
Prior external beam radiation therapy to more than 25% of the bone marrow
Lab requirements
Blood counts
Hb > 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³
Kidney function
estimated GFR (MDRD) < 40 mL/min or nephrotic syndrome
Liver function
ALT/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
Cardiac function
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)
Adequate bone marrow reserve (Hb > 8 g/dl, neutrophils ≥ 1500/mm³ and platelets ≥ 80 000/mm³), 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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