Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016855
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-08-23
Brief Title:
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy PRRT in Patients With Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This phase IV trial evaluates how well giving standard of care SOC peptide receptor radionuclide therapy PRRT after SOC surgical removal of as much tumor as possible debulking surgery works in treating patients with grade 1 or 2 somatostatin receptor SSTR positive gastroenteropancreatic neuroendocrine tumors GEP-NETs that have spread from where they first started primary site to the liver hepatic metastasis Lutetium Lu 177 dotatate is a radioactive drug that uses targeted radiation to kill tumor cells Lutetium Lu 177 dotatate includes a radioactive form an isotope of the element called lutetium This radioactive isotope Lu-177 is attached to a molecule called dotatate On the surface of GEP-NET tumor cells a receptor called a somatostatin receptor binds to dotatate When this binding occurs the lutetium Lu 177 dotatate drug then enters somatostatin receptor-positive tumor cells and radiation emitted by Lu-177 helps kill the cells Giving lutetium Lu 177 dotatate after surgical debulking may better treat patients with grade 12 GEP-NETs
Detailed Description:
PRIMARY OBJECTIVES
I To measure objective response rate of a combination standard of care treatment in gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90 days of surgical debulking
II To assess the radiomic profile including somatostatin receptor standardized uptake values SSTR SUV of large and non-large tumors in study patients
III To assess the safety and tolerability of peptide receptor radionuclide therapy PRRT post-surgical debulking in patients on study
IV To assess the tumor genomic profile of large resected tumors from patients and assess for signatures of radioresistance
OUTLINE
Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate 177Lu dotatate intravenously IV over 30 to 40 minutes on day 1 of each cycle Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan or magnetic resonance imaging MRI throughout the trial and undergo copper Cu 64 dotatate positron emission tomographyCT dotatate PETCT during screening and on study
After completion of study treatment patients are followed up at 30-37 days after last dose and then every 3 months for 2 years
I To measure objective response rate of a combination standard of care treatment in gastroenteropancreatic neuroendocrine tumors by initiating lutetium Lu 177 dotatate within 90 days of surgical debulking
II To assess the radiomic profile including somatostatin receptor standardized uptake values SSTR SUV of large and non-large tumors in study patients
III To assess the safety and tolerability of peptide receptor radionuclide therapy PRRT post-surgical debulking in patients on study
IV To assess the tumor genomic profile of large resected tumors from patients and assess for signatures of radioresistance
OUTLINE
Patients undergo surgical debulking on day 0 and receive lutetium Lu 177 dotatate 177Lu dotatate intravenously IV over 30 to 40 minutes on day 1 of each cycle Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients undergo computed tomography CT scan or magnetic resonance imaging MRI throughout the trial and undergo copper Cu 64 dotatate positron emission tomographyCT dotatate PETCT during screening and on study
After completion of study treatment patients are followed up at 30-37 days after last dose and then every 3 months for 2 years
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05914 | REGISTRY | NCI Clinical Trials Reporting Program | None |