Actively Recruiting
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
100
Participants Needed
36
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus, sunitinib, or cabozantinib in patients who have previously received 177Lu-DOTATATE for gastroenteropancreatic neuroendocrine tumor (GEPNET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable). PRRT is a type of radiation therapy for which a radioactive chemical is linked to a peptide (small protein) that targets tumor cells. When this radioactive peptide is injected into the body, it binds to a specific receptor found on some tumor cells. The radioactive peptide builds up in these cells and helps kill the tumor cells without harming normal cells. In this trial 177Lu-DOTATATE is used for PRRT. 177Lu-DOTATATE PRRT may increase the length of time until worsening of the GEPNET compared to the usual approach. Everolimus is in a class of medications called kinase inhibitors. It is also a type of angiogenesis inhibitor. Everolimus works by stopping tumor cells from reproducing and by decreasing blood supply to the tumor cells. Sunitinib and cabozantinib, block certain proteins, which may help keep tumor cells from growing. They may also prevent the growth of new blood vessels that tumors need to grow. Sunitinib malate is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Retreating with 177Lu-DOTATATE may work better than everolimus, sunitinib or cabozantinib in shrinking or stabilizing tumors in patients with metastatic and unresectable GEPNET who were previously treated with 177Lu-DOTATATE.
CONDITIONS
Official Title
Comparing Retreatment of 177Lu-DOTATATE PRRT Versus the Usual Treatment in Patients With Metastatic Unresectable Gastroenteropancreatic Neuroendocrine Tumors, NET RETREAT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years old
- Metastatic, histologically confirmed grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumors
- Positive Gallium-68 DOTATATE, Copper-64 DOTATATE, or octreotide scan within 36 months
- Previously received 3 or 4 cycles of 177Lu-DOTATATE PRRT or cumulative dose within 52 weeks
- Radiological progression after prior PRRT with at least 12 months of benefit from initial PRRT
- Allowed previous systemic anti-cancer therapy following initial PRRT under certain conditions
- No ongoing severe toxicity (grade 3 or higher) from prior PRRT
- ECOG performance status of 2 or less
- Hemoglobin >= 80 g/L, absolute neutrophil count >= 1.0 x 10^9/L, platelets >= 80 x 10^9/L within 28 days prior to enrollment
- Total bilirubin less than 1.5 times upper limit of normal (or <=3.0 x ULN if Gilbert's syndrome)
- Creatinine clearance over 50 mL/min within 28 days prior to enrollment
- Prior or current somatostatin analogues allowed for functional control
- Signed informed consent
- Agree to use effective contraception during and after treatment
- Accessible for treatment, response assessment, and follow-up
- Access to everolimus, sunitinib, or cabozantinib as applicable
- HIV patients on effective antiretroviral therapy with undetectable viral load are eligible
- Patients with prior or concurrent malignancies not interfering with study participation are eligible
You will not qualify if you...
- Major surgery within 6 weeks before randomization
- Known brain metastases unless treated, stabilized, and off steroids for at least 4 weeks with documented stable disease
- Uncontrolled congestive heart failure worse than NYHA Class IIB
- Inability to swallow oral medications or gastrointestinal disorders limiting oral drug absorption
- Any other significant uncontrolled medical or surgical condition that may interfere with study completion
- Pregnant women
- Breastfeeding mothers must discontinue breastfeeding during treatment and for 2.5 months after last 177Lu-DOTATATE dose
AI-Screening
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Trial Site Locations
Total: 36 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Suspended
2
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
Banner University Medical Center - Tucson
Tucson, Arizona, United States, 85719
Actively Recruiting
4
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States, 85719
Actively Recruiting
5
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
6
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
7
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Suspended
10
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
12
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
13
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
14
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
15
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
16
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
17
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States, 60451
Actively Recruiting
18
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
19
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
20
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
21
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
22
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
23
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
24
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Suspended
25
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
26
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
27
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
28
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
29
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
30
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
31
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
32
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Suspended
33
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
34
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Actively Recruiting
35
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
36
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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