Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
Summary
The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.
Detailed description
Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT). A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.
Arms & interventions
- ProcedurePeptide Receptor Radionuclide Therapy
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
Outcome measures
Primary
Demographics and other patient data
(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
Time frame: 7 years from date of procedure
Tumor specific data
Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)
Time frame: 7 years from date of procedure
Use of somatostatin analogs
at the time of PRRT, location, isotope used and dose of isotope for each PRRT
Time frame: 7 years from date of procedure
Biomarker data (chromogranin A and pancreastatin)
at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted
Time frame: 7 years from date of procedure
Diagnostic imaging findings
prior to PRRT and response after PRRT, date of progression on imaging after PRRT, and status of disease on imaging at the last follow-up were also recorded
Time frame: 7 years from date of procedure
Overall survival (OS)
the time from diagnosis to death of any cause.
Time frame: 7 years from date of procedure
Time to progression (TTP)
the time from the first PRRT until any progression on diagnostic imaging
Time frame: 7 years from date of procedure
Treatment responses and progression
assessed with cross-sectional imaging with either computerized tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) or single-photon emission computed tomography (SPECT).
Time frame: 7 years from date of procedure
Response
any response of any magnitude
Time frame: 7 years from date of procedure
Disease progression
any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.
Time frame: 7 years from date of procedure
Adverse events
will be assessed by the investigator who will determine whether or not the event is related to PRRT or related to progression of disease (gastroenteropancreatic primary NET), and whether or not the event meets serious criteria. AEs related to PRRT will be recorded in the study registry.
Time frame: 7 years from date of procedure
Eligibility criteria
Study locations (2)
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Methodist Dallas Medical Center
Dallas, Texas, 75203