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 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,
Parallel
Lutathera
Drug2 additional infusions of Lutathera®
Evaluate the efficacy of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance during 6 months in patients already retreated with two cycles.
defined as a change of tumoral assessment (Complete Response, Partial Response and Stable Disease from RECIST v1.1) with an evaluation every 2 months.
Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Safety
Number and type of adverse event according to NCI-CTCAE v5.0.
Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Progression free survival
the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first
Evaluate the impact of two additional cycles of Lutathera® (one injection every two months), compared to active surveillance in term of Overall survival
the time from randomization until death from any cause.
To assess quality of life of general patient
Quality of life will be measured by EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality-of-life questionnaire C30, no min and max values)
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