A Study Comparing Lutetium Edotreotide with Standard Treatments in People with Digestive Neuroendocrine Tumors

Full Title

A Prospective, Randomized, Controlled, Open-label, Multicenter Trial to Evaluate Efficacy, Safety and Patient-reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) with Lutetium (177Lu) Edotreotide compared to Best Standard of Care in Patients with Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor positive (SSTR+), Neuroendocrine Tumors of GastroEnteric or Pancreatic Origin (COMPOSE) (WIRB)

Purpose

The purpose of this study is to compare the effectiveness of lutetium (177Lu) edotreotide with standard therapies in people with neuroendocrine tumors of the stomach, intestines, or pancreas. Lutetium edotreotide binds to a protein on cancer cell surfaces called the somatostatin receptor and releases radiation to kill the cancer cell.

Participants in this study will be randomly assigned to receive either lutetium edotreotide or one of these standard chemotherapy regimens:

• Capecitabine and temozolomide
• Folinic acid, fluorouracil, and oxaliplatin
• Everolimus

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

• Participants must have an inoperable neuroendocrine tumor of the stomach, intestines, or pancreas that contains receptors for somatostatin.
• Patients may have received one prior regimen of therapy, and it must have been completed at least 4 weeks before receiving the study treatment.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for people age 18 and older.

For more information and to ask about eligibility for this study, please contact the office of Dr. Nitya Raj at 646-888-4849.