Phase
Condition
Abdominal Cancer
Digestive System Neoplasms
Carcinoid Syndrome And Carcinoid Tumours
Treatment
CAPTEM (Capecitabine and Temozolomide)
Everolimus
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients aged ≥ 18 years.
Histologically confirmed diagnosis of unresectable, well-differentiatedGastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of diseaseper RECIST v1.1 (Response evaluation criteria in solid tumors) using contrastcomputed tomography (CT) / magnetic resonance imaging (MRI).
Somatostatin receptor-positive (SSTR+) disease.
Exclusion
Exclusion Criteria:
Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraaceticacid), 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 7half-life periods (whichever is longer) prior to randomization.
Other known malignancies.
Serious non-malignant disease.
Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentiallyinterfering with the safety of the trial treatments.
Pregnant or breastfeeding women.
Patients not able to declare meaningful informed consent on their own or any othervulnerable population to that.
Study Design
Connect with a study center
Royal North Shore Hospital
St. Leonards, New South Wales 2065
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria VIC 3000
AustraliaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, 200000
ChinaSite Not Available
Affiliated Hospital of Jiangnan University
Wuxi, 214122
ChinaSite Not Available
Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
Pessac, Bordeaux 33604
FranceSite Not Available
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, Cedex 44093
FranceSite Not Available
Edouard Herriot Hospital, Medical Oncology Unit
Lyon, 69003
FranceSite Not Available
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
Toulouse, 31059
FranceSite Not Available
Charite - University Hospital Berlin
Berlin, 13353
GermanySite Not Available
University Hospital Bonn, Department of Nuclear Medicine
Bonn, 53127
GermanySite Not Available
University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
Erlangen, 91054
GermanySite Not Available
University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
Essen, 45147
GermanySite Not Available
All India Institute Of Medical Sciences, Nuclear Medicine
New Delhi, Delhi 110029
IndiaSite Not Available
HCG Cancer Centre, Medical Oncology
Bangalore, Karnataka 560027
IndiaSite Not Available
Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
Mumbai, 400012
IndiaSite Not Available
University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
Messina, 98125
ItalySite Not Available
European Institute of Oncology (IEO), IRCCS
Milan, 20141
ItalySite Not Available
University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology
Naples, 80131
ItalySite Not Available
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
Rome, 00168
ItalySite Not Available
VU Medical Center (VUMC), Department of Medical Oncology
Amsterdam, 1081-HV
NetherlandsSite Not Available
Erasmus University Medical Center Rotterdam
Rotterdam, 3015 GD
NetherlandsSite Not Available
ICO Hospitalet, Catalan Institute of Oncology
Barcelona, 199-203
SpainSite Not Available
University Hospital Vall d'Hebron, Department of Medical Oncology
Barcelona, 08035
SpainSite Not Available
University General Hospital Gregorio Maranon
Madrid, 28007
SpainSite Not Available
University Hospital 12 de Octubre, Department of Gastroenterology
Madrid, 28041
SpainSite Not Available
Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
Oviedo, 33011
SpainSite Not Available
University Hospital Complex of Santiago (CHUS)
Santiago De Compostela, 15706
SpainSite Not Available
University and Polytechnic Hospital La Fe, Endocrinology
Valencia, 46026
SpainSite Not Available
Uppsala University Hospital, Department of Oncology
Uppsala, 75185
SwedenSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
Royal Free Hospital
London, NW3 2QG
United KingdomSite Not Available
Stanford Cancer Center
Palo Alto, California 94305
United StatesSite Not Available
University of Colorado Hospital, Nuclear Medicine
Aurora, Colorado 80045
United StatesSite Not Available
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida 33612
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Mayo Clinic - Rochester, Department of Oncology
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University Alvin J. Siteman Cancer Center
Saint Louis, Missouri 63110
United StatesSite Not Available
ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute
New York, New York 10128
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Duke University School of Medicine, Duke Cancer Institute
Durham, North Carolina 27710
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239-3098
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111-2497
United StatesSite Not Available
Scott Paulson
Dallas, Texas 75246
United StatesActive - Recruiting
Texas Oncology
Dallas, Texas 75246
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.