Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
NCT ID: NCT04919226
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
259 participants
INTERVENTIONAL
2021-12-21
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peptide Receptor Radionuclide Therapy (PRRT) Arm
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
CAPTEM (Capecitabine and Temozolomide)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
Everolimus
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
Interventions
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177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
CAPTEM (Capecitabine and Temozolomide)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Everolimus
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Best standard of care treatment (investigator's choice \[from the protocol comparator list\]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
* Somatostatin receptor-positive (SSTR+) disease.
Exclusion Criteria
* Prior (Peptide Receptor Radionuclide Therapy) PRRT.
* Any major surgery within 4 weeks prior to randomization in the trial.
* Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
* Other known malignancies.
* Serious non-malignant disease.
* Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
* Pregnant or breastfeeding women.
* Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.
18 Years
ALL
No
Sponsors
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ITM Solucin GmbH
INDUSTRY
Responsible Party
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Locations
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Stanford Cancer Center
Palo Alto, California, United States
University of Colorado Hospital, Nuclear Medicine
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - Rochester, Department of Oncology
Rochester, Minnesota, United States
Washington University Alvin J. Siteman Cancer Center
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute
New York, New York, United States
Duke University School of Medicine, Duke Cancer Institute
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Texas Oncology
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Fudan University Shanghai Cancer Center
Shanghai, , China
Affiliated Hospital of Jiangnan University
Wuxi, , China
Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
Pessac, Bordeaux, France
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, Cedex, France
Edouard Herriot Hospital, Medical Oncology Unit
Lyon, , France
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
Toulouse, , France
Charite - University Hospital Berlin
Berlin, , Germany
University Hospital Bonn, Department of Nuclear Medicine
Bonn, , Germany
University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
Erlangen, , Germany
University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
Essen, , Germany
HCG Cancer Centre, Medical Oncology
Bangalore, Karnataka, India
All India Institute Of Medical Sciences, Nuclear Medicine
New Delhi, National Capital Territory of Delhi, India
Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
Mumbai, , India
University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
Messina, , Italy
European Institute of Oncology (IEO), IRCCS
Milan, , Italy
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
Rome, , Italy
VU Medical Center (VUMC), Department of Medical Oncology
Amsterdam, , Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, , Netherlands
University Hospital Vall d'Hebron, Department of Medical Oncology
Barcelona, , Spain
ICO Hospitalet, Catalan Institute of Oncology
Barcelona, , Spain
University General Hospital Gregorio Maranon
Madrid, , Spain
University Hospital 12 de Octubre, Department of Gastroenterology
Madrid, , Spain
Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
Oviedo, , Spain
University Hospital Complex of Santiago (CHUS)
Santiago de Compostela, , Spain
University and Polytechnic Hospital La Fe, Endocrinology
Valencia, , Spain
King's College Hospital
London, , United Kingdom
Countries
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Other Identifiers
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DP-1111-02CT
Identifier Type: -
Identifier Source: org_study_id
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