Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02736448
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2016-04-07
Brief Title:
177Lutethium - Peptide Receptor Radionuclide Therapy Lu-PRRT Plus Capecitabine Versus Lu-PRRT in FDG Positive Gastro-entero-pancreatic Neuroendocrine Tumors
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
177Lutethium - Peptide Receptor Radionuclide Therapy Lu-PRRT Plus Capecitabine Versus Lu-PRRT in FDG Positive Gastro-entero-pancreatic Neuroendocrine Tumors a Randomized Phase II Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Lu-Ca-S
Brief Summary:
This is a randomized phase II parallel group study Patients with gastro-entero-pancreatic neuroendocrine tumors GEP-NET well differentiated G1 - G2 ki67 20 and G3 ki67 50 somatostatin receptor SSR positive and 18-FDG positive will be enrolled in the study and will be randomly assigned to 2 different arms
Arm Lu-PRRT-Cap oral low dose of capecitabine in association with Lu-PRRT at 37 Gbq per cycle x 7 cycles followed by long acting octreotide or lanreotide SS-LAR OR
Arm Lu-PRRT Lu-PRRT at 37 gigabecquerel Gbq per cycle x 7 cycles followed by SS-LAR
Arm Lu-PRRT-Cap oral low dose of capecitabine in association with Lu-PRRT at 37 Gbq per cycle x 7 cycles followed by long acting octreotide or lanreotide SS-LAR OR
Arm Lu-PRRT Lu-PRRT at 37 gigabecquerel Gbq per cycle x 7 cycles followed by SS-LAR
Detailed Description:
This is a randomized phase II parallel group study Patients with gastro-entero-pancreatic neuroendocrine tumors GEP-NET well differentiated G1 - G2 ki67 20 and G3 ki67 50 SSR positive and 18-fluorodeoxyglucose FDG positive will be enrolled in the study and will be randomly assigned to 2 different arms
Arm Lu-PRRT-Cap oral low dose of capecitabine in association with Lu-PRRT at 37 Gbq per cycle x 7 cycles followed by long acting octreotide or lanreotide SS-LAR OR
Arm Lu-PRRT Lu-PRRT at 37Gbq per cycle x 7 cycles followed by SS-LAR The primary objective is to evaluate the progression free survival PFS in the two arms
The secondary objectives are i the efficacy disease control rate DCR ii acute and late toxicity and iii overall survival OS
The investigators plan to enroll 176 patients during a period of 36 months and a period of 36 months of follow up
Arm Lu-PRRT-Cap oral low dose of capecitabine in association with Lu-PRRT at 37 Gbq per cycle x 7 cycles followed by long acting octreotide or lanreotide SS-LAR OR
Arm Lu-PRRT Lu-PRRT at 37Gbq per cycle x 7 cycles followed by SS-LAR The primary objective is to evaluate the progression free survival PFS in the two arms
The secondary objectives are i the efficacy disease control rate DCR ii acute and late toxicity and iii overall survival OS
The investigators plan to enroll 176 patients during a period of 36 months and a period of 36 months of follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2014-003067-38 | EUDRACT_NUMBER | None | None |