Purpose of this Study
We are doing this study to compare the study drug, lutetium-177 edotreotide, to existing standard-of-care therapies.
Who Can Participate?
Eligibility
Adults with a gastroenteropancreatic neuroendocrine tumor (GEP-NET) that is:
- Unresectable (cannot be surgically removed)
- Well differentiated
- High grade 2 or grade 3 (Ki-67 index of 15 to 55)
- Somatostatin receptor positive (SSTR+)
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
- Unresectable (cannot be surgically removed)
- Well differentiated
- High grade 2 or grade 3 (Ki-67 index of 15 to 55)
- Somatostatin receptor positive (SSTR+)
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study, you will:
- Be assigned to get either the study drug or an existing therapy (CAPTEM, everolimus, or FOLFOX)
- Get up to 6 IV administrations of the study drug 6-8 weeks apart (if assigned) OR take pills and/or get IV administrations of your assigned standard-of-care therapy
- Give blood and urine samples
- Have regular CT or MRI scans
- Be assigned to get either the study drug or an existing therapy (CAPTEM, everolimus, or FOLFOX)
- Get up to 6 IV administrations of the study drug 6-8 weeks apart (if assigned) OR take pills and/or get IV administrations of your assigned standard-of-care therapy
- Give blood and urine samples
- Have regular CT or MRI scans
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
[DP-1111-02CT] 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)
Principal Investigator
Michael
Morse
Protocol Number
PRO00108718
NCT ID
NCT04919226
Phase
III
Enrollment Status
OPEN TO ACCRUAL