Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04954820
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2021-06-11
Brief Title:
Assessment of Retreatment With Lutathera in Patients With New Progression of Intestinal Well-differenciated NET
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
A Prospective Randomized Phase II Study Assess the Schema of Retreatment With Lutathera 177LULU-DOTA-TATE in Patients With New Progression of Intestinal Well-differenciated Neuroendocrine Tumor
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReLUTH
Brief Summary:
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
Detailed Description:
The NETTER-1 clinical trial compared peptide receptor radionuclide therapy PRRT with 177LuLu-DOTA-TATE Lutathera every eight weeks 4 doses plus 30 mg octreotide LAR every 4 weeks with high dose 60 mg of octreotide LAR every 4 weeks in patients with progressive and unresectable midgut neuroendocrine well differentiated G1 G2 tumors NETs with somatostatin-receptor positive imaging SSTRi Lutathera improves both median progression free survival PFS 284 months vs 85 months and median overall survival OS not reached vs 274 months with a follow-up of 42 months Lutathera also has an impact on quality of life Therefore this treatment was approved by the European Medicines Agency and is now reimbursed in France in that specific indication Despite these promising results progression will occur in most of patients within a variable time with limited treatment options left Retreatment with additional cycles of Lutathera may be an option Van der Zwan et al showed in a large retrospective cohort the ROTTERDAM cohort a median PFS of 146 months after retreatment with two additional cycles of PRRT with 177LuLu-DOTA-TATE and a significant longer OS than in the non-randomized control group Interestingly the safety was similar in salvage group than in initial PRRT no grade G 34 renal toxicity occurred and hematological toxicities were similar to the group of patients who received the initial treatment 4 cycles In a smaller cohort of 15 patients Yordanova et al showed that 8 or more cycles of 177LuLu-DOTA-TATE were well tolerated and led to a survival improvement In this study each salvage therapy consisted of 2 or 3 cycles No severe G3 G4 renal toxicity or G4 adverse event occurred 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None