Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04029428
Status:
UNKNOWN
Last Update Posted:
2020-04-01
First Post:
2019-05-19
Brief Title:
Peptide Receptor Radionuclide Therapy in the Treatment of Advanced Non-resectable andor Symptomatic Tumors With SSTR Overexpression
Sponsor:
University of Warmia and Mazury
Organization:
University of Warmia and Mazury
Study Overview
Official Title:
Clinical Study of the Use of Yttrium-90 90Y andor Lutecium-177 177Lu DOTATATE DOTA-0-Tyr3-Octreotate in the Treatment of Disseminated and or Symptomatic Tumors With Somatostatin Receptor Overexpression
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
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:
POLNETS_PRRT
Brief Summary:
This is a non-randomized phase II open label comparative study Patients with advanced non-resectable andor progressive gastro-entero-pancreatic Neuroendocrine Tumours - GEP-NET G1 G2 and G3 Broncho-pulmonary Carcinoids BPCs Atypical-AC or Typical-TC pheochromocytomaparaganglioma PPGLs and neuroendocrine tumours of unknown primary NET-CUP with overexpression of somatostatin receptor SSTR positive will be enrolled in the study and will be treated using Peptide Receptor Radionuclide Therapy PRRT initially with Yttrium-90 90Y DOTATATE DOTA-0-Tyr3-Octreotate and then compare to Lutecium-177 177Lu DOTATATE or mix of both Yttrium-90 90Y and Lutecium-177 177Lu DOTATATE Total maximum activity for Yttrium-90 up to 4x37GBq for Lutecium-177 up to 4x555GBq Lu-177 and for both mix 4x37GBq 90Y and 177Lu 50 each
Detailed Description:
This is a non-randomized phase II open-label comparative study Patients with advanced unresectable andor progressive Gastro-Entero-Pancreatic Neuroendocrine Tumors - GEP-NET histological grade G1 G2 and G3 Broncho-Pulmonary Carcinoids BPCs including typical carcinoid AC and typical carcinoid TC pheochromocytomaparagangliomas PPGLs and neuroendocrine tumors cancers of unknown primary NET-CUP All with overexpression of somatostatin receptor SSTR positive based on somatostatin receptor imaging scintigraphy or PET will be enrolled in this study
Initially patients will be assigned to single arm of PRRT using yttrium-90 90Y DOTATATE DOTA-0-Tyr3-Octreotate and then patients will be non-randomly assigned to one of the two groups lutecium-177 177Lu DOTATATE or mix yttrium 90Y DOTATATE and lutecium-177 177Lu DOTATATE 50 each The dosages total activity used in each group of treated patients will be as follows
1 Total activity of 90Y DOTATATE 4x37GBq 148 GBq for 4 cycles at 8 2 weeks 400mCi
2 Total activity of 177Lu DOTATATE 4x555GBq 222 GBq for 4 cycles at 8 2 weeks 600 mCi
3 Total activity of mix both 90Y DOTATATE and 177Lu DOTATATE 50 each 4x37 GBq for 4 cycles at 8 2 weeks 400mCi
The non-randomized phase II study design allows for proposed initial active treatment arm using standard dose of 90Y DOTATATE and experimental treatment arm which composed of two options of PRRT with lutecium-177 DOTATATE or mix 90Y and 177Lu DOTATATE The experimental therapy arm will be consisting of randomly allocated patients
Subjects including in this study will be evaluated in the mixed patients population including GEP-NET bronchopulmonary carcinoid BPCs paragangliomapheochromocytomas PPGLs and NET of unknown origin NET-CUP
Estimates of the original goals of the study can be assessed for each scheme separately using a two-step design using an external standard for comparison the investigators previous published results include standard PRRT using 90Y DOTATATE in subjects with GEP-NET
Although the sample size in this study is not based on any specific statistical hypothesis to compare separate groups of patients those with PRRT using 90Y DOTATATE next those with 177Lu DOTATATE and those who will receive mix 90Y and 177Lu DOTATATE
This study design allows an objective set of clinical efficacy results in terms of PRRT responses and safety in these three treatment regimens in the same patient population even different groups of tumors which may be useful when planning next generation of the clinical trial using PRRT
Initially patients will be assigned to single arm of PRRT using yttrium-90 90Y DOTATATE DOTA-0-Tyr3-Octreotate and then patients will be non-randomly assigned to one of the two groups lutecium-177 177Lu DOTATATE or mix yttrium 90Y DOTATATE and lutecium-177 177Lu DOTATATE 50 each The dosages total activity used in each group of treated patients will be as follows
1 Total activity of 90Y DOTATATE 4x37GBq 148 GBq for 4 cycles at 8 2 weeks 400mCi
2 Total activity of 177Lu DOTATATE 4x555GBq 222 GBq for 4 cycles at 8 2 weeks 600 mCi
3 Total activity of mix both 90Y DOTATATE and 177Lu DOTATATE 50 each 4x37 GBq for 4 cycles at 8 2 weeks 400mCi
The non-randomized phase II study design allows for proposed initial active treatment arm using standard dose of 90Y DOTATATE and experimental treatment arm which composed of two options of PRRT with lutecium-177 DOTATATE or mix 90Y and 177Lu DOTATATE The experimental therapy arm will be consisting of randomly allocated patients
Subjects including in this study will be evaluated in the mixed patients population including GEP-NET bronchopulmonary carcinoid BPCs paragangliomapheochromocytomas PPGLs and NET of unknown origin NET-CUP
Estimates of the original goals of the study can be assessed for each scheme separately using a two-step design using an external standard for comparison the investigators previous published results include standard PRRT using 90Y DOTATATE in subjects with GEP-NET
Although the sample size in this study is not based on any specific statistical hypothesis to compare separate groups of patients those with PRRT using 90Y DOTATATE next those with 177Lu DOTATATE and those who will receive mix 90Y and 177Lu DOTATATE
This study design allows an objective set of clinical efficacy results in terms of PRRT responses and safety in these three treatment regimens in the same patient population even different groups of tumors which may be useful when planning next generation of the clinical trial using PRRT
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