Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
- Conditions
- Neuroendocrine Tumors
- Interventions
- Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRTDrug: CAPTEM (Capecitabine and Temozolomide)Other: Amino-Acid SolutionDrug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
- Registration Number
- NCT04919226
- Lead Sponsor
- ITM Solucin GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Patients aged ≥ 18 years.
- 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.
- Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peptide Receptor Radionuclide Therapy (PRRT) Arm 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT - CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) - CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) CAPTEM (Capecitabine and Temozolomide) - Peptide Receptor Radionuclide Therapy (PRRT) Arm Amino-Acid Solution - CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) Everolimus -
- Primary Outcome Measures
Name Time Method Progression-Free Survival Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events. PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.
- Secondary Outcome Measures
Name Time Method Overall Survival Up to 2 years after disease progression OS (Overall Survival), defined as the time from randomization until death;
Trial Locations
- Locations (45)
ICO Hospitalet, Catalan Institute of Oncology
🇪🇸Barcelona, Spain
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, China
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
🇺🇸Saint 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
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
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 Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology
🇮🇹Naples, Italy
VU Medical Center (VUMC), Department of Medical Oncology
🇳🇱Amsterdam, Netherlands
Erasmus University Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
All India Institute Of Medical Sciences, Nuclear Medicine
🇮🇳New Delhi, Delhi, India
HCG Cancer Centre, Medical Oncology
🇮🇳Bangalore, Karnataka, India
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
🇮🇹Rome, Italy
University Hospital Vall d'Hebron, Department of Medical 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
Uppsala University Hospital, Department of Oncology
🇸🇪Uppsala, Sweden
Royal Free Hospital
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom