Ignite Creation Date:
2024-05-06 @ 12:27 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01578239
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2012-04-10
Brief Title:
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable Progressive Somatostatin Receptor Positive Midgut Carcinoid Tumours
Sponsor:
Advanced Accelerator Applications
Organization:
Advanced Accelerator Applications
Study Overview
Official Title:
A Multicentre Stratified Open Randomized Comparator-controlled Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable Progressive Somatostatin Receptor Positive Midgut Carcinoid Tumours
Status:
COMPLETED
Status Verified Date:
2022-02
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:
NETTER-1
Brief Summary:
This was a multicenter stratified open randomized comparator-controlled parallel-group phase III study comparing treatment with Lutathera plus best supportive care 30 mg Octreotide LAR to treatment with high dose 60 mg Octreotide LAR in participants with metastasized or locally advanced inoperable somatostatin receptor positive histologically proven midgut carcinoid tumours with progression despite LAR treatment
Detailed Description:
After the screening period participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutathera or Octreotide LAR Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio 11 between the 2 treatment groups stratified by tumor uptake score and by the length of time that a participant was on a constant dose of Octreotide 6 versus 6 months
Objective tumor assessment in both groups was performed every 12-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed
1 Any participants with progressive disease confirmed by central review of CTMRI scans ceased the treatmentassessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety
2 All non-progressive participants continued treatmentassessments until the PFS primary endpoint was met ie 74 evaluable and centrally confirmed disease progressions or death events Once the Primary End-Point was reached
1 Participants who received more than 76 weeks of treatmentassessment stopped the study treatment however somatostatin analogues could be received as subsequent treatment as per Investigators discretion but continued the long-term follow-up assessment for 5 years overall from the date of randomization of the last participant randomized
2 The remaining randomized participants continued in the fixed 76-week treatmentassessment period unless progression occurred then continued the long-term follow-up assessments for 5 years overall from the date of randomization of the last participant
Objective tumor assessment in both groups was performed every 12-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed
1 Any participants with progressive disease confirmed by central review of CTMRI scans ceased the treatmentassessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety
2 All non-progressive participants continued treatmentassessments until the PFS primary endpoint was met ie 74 evaluable and centrally confirmed disease progressions or death events Once the Primary End-Point was reached
1 Participants who received more than 76 weeks of treatmentassessment stopped the study treatment however somatostatin analogues could be received as subsequent treatment as per Investigators discretion but continued the long-term follow-up assessment for 5 years overall from the date of randomization of the last participant randomized
2 The remaining randomized participants continued in the fixed 76-week treatmentassessment period unless progression occurred then continued the long-term follow-up assessments for 5 years overall from the date of randomization of the last participant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAAA601A12301 | OTHER | Novartis | None |
| 2011-005049-11 | EUDRACT_NUMBER | None | None |