Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Public ClinicalTrials.gov record NCT04919226. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the efficacy, safety \& patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
Study identification
- NCT ID
- NCT04919226
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 259 participants
Conditions and interventions
Conditions
Interventions
- 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Drug
- CAPTEM (Capecitabine and Temozolomide) Drug
- Amino-Acid Solution Other
- Everolimus Drug
- FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 21, 2021 (Actual)
- Primary completion
- Jun 2027 (Estimated)
- Completion
- Sep 2027 (Estimated)
- Last update posted
- Sep 10, 2025
2021 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94305 | — |
| University of Colorado Hospital, Nuclear Medicine | Aurora | Colorado | 80045 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic - Rochester, Department of Oncology | Rochester | Minnesota | 55905 | — |
| Washington University Alvin J. Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute | New York | New York | 10128 | — |
| Duke University School of Medicine, Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| Oregon Health and Science University | Portland | Oregon | 97239-3098 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | — |
| Texas Oncology | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04919226, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2025 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04919226 live on ClinicalTrials.gov.