Study on the Effectiveness and Safety of 177Lu-edotreotide Therapy in Patients with Gastroenteric or Pancreatic Neuroendocrine Tumors
Sponsor: ITM Solucin GmbH
ClinicalTrials ID:NCT03049189
This clinical trial is testing a new treatment called 177Lu-edotreotide PRRT to see if it is effective and safe for patients with certain types of neuroendocrine tumors that cannot be removed by surgery. The study compares this treatment to another drug called Everolimus.
Patient Parameters
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Program Overview
The aim of this study is to find out if a treatment called Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-Edotreotide is effective and safe for patients with neuroendocrine tumors in the stomach, intestines, or pancreas that cannot be surgically removed. These tumors must be growing and have a specific marker called somatostatin receptor-positive (SSTR+). The study will compare this new treatment to a standard drug called Everolimus.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of a well-differentiated neuroendocrine tumor in the stomach, intestines, or pancreas.
- The tumor must be measurable using standard imaging techniques.
- The tumor must have a specific marker called somatostatin receptor-positive (SSTR+).
- The disease must be progressing, as shown by two imaging tests using the same method (either CT or MRI).
Exclusion Criteria
- Have allergies to edotreotide, everolimus, or similar substances.
- Have had previous treatments with similar therapies, such as PRRT or mTor inhibitors.
- Have received certain types of radiation therapy to the tumor within 90 days before joining the study.
- Have participated in another clinical trial or used an investigational treatment within 30 days before joining the study.
- Have a tumor that can be surgically removed with a chance of cure.
- Have plans for other treatments during the study period.
- Have serious non-cancerous diseases or organ dysfunctions that could affect the study treatment's safety.
- Are pregnant or breastfeeding.
- Are unable to give informed consent on their own, such as those with mental disorders or those who are institutionalized or incarcerated.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner Health d.b.a. Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Stanford University | 94305 | Stanford | California |
| Moffitt Cancer Center & Research Institute | 33612 | Tampa | Florida |
| Northwestern Memorial Hospital | 60611 | Chicago | Illinois |
| University of Michigan Comprehensive Cancer Center | 48109 | Ann Arbor | Michigan |
| Excel Diagnostics & Nuclear Oncology Center | 77042 | Houston | Texas |
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