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.
• 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