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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)

Primary Purpose

Neuroendocrine Tumors

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
CAPTEM (Capecitabine and Temozolomide)
Amino-Acid Solution
Everolimus
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Sponsored by
ITM Solucin GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring GastroEnteroPancreatic, non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Stanford Cancer CenterRecruiting
  • University of Colorado Hospital, Nuclear MedicineRecruiting
  • H. Lee Moffitt Cancer Center & Research InstituteRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Mayo Clinic - Rochester, Department of OncologyRecruiting
  • Washington University Alvin J. Siteman Cancer CenterRecruiting
  • Memorial Sloan-Kettering Cancer CenterRecruiting
  • Duke University School of Medicine, Duke Cancer InstituteRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Fox Chase Cancer CenterRecruiting
  • Scott PaulsonRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • University of Utah, Huntsman Cancer InstituteRecruiting
  • Royal North Shore HospitalRecruiting
  • Peter MacCallum Cancer Centre
  • Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract OncologyRecruiting
  • Nantes University Hospital Center - Hotel Dieu HospitalRecruiting
  • Edouard Herriot Hospital, Medical Oncology UnitRecruiting
  • IUCT Oncopole - Institut Universitaire du Cancer de ToulouseRecruiting
  • Charite - University Hospital BerlinRecruiting
  • University Hospital Bonn, Department of Nuclear MedicineRecruiting
  • University Hospital Erlangen, Department of Internal Medicine I - EndocrinologyRecruiting
  • University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear MedicineRecruiting
  • All India Institute Of Medical Sciences, Nuclear Medicine
  • HCG Cancer Centre, Medical Oncology
  • Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
  • University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear MedicineRecruiting
  • European Institute of Oncology (IEO), IRCCSRecruiting
  • University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and OncologyRecruiting
  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical OncologyRecruiting
  • VU Medical Center (VUMC), Department of Medical OncologyRecruiting
  • University Hospital Vall d'Hebron, Department of Medical OncologyRecruiting
  • ICO Hospitalet, Catalan Institute of OncologyRecruiting
  • University Hospital 12 de Octubre, Department of GastroenterologyRecruiting
  • Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of OncologyRecruiting
  • University Hospital Complex of Santiago (CHUS)Recruiting
  • University and Polytechnic Hospital La Fe, EndocrinologyRecruiting
  • Uppsala University Hospital, Department of Oncology
  • Royal Free Hospital
  • King's College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Peptide Receptor Radionuclide Therapy (PRRT) Arm

CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival
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

Overall Survival
OS (Overall Survival), defined as the time from randomization until death;

Full Information

First Posted
June 1, 2021
Last Updated
September 12, 2023
Sponsor
ITM Solucin GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04919226
Brief Title
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE
Acronym
COMPOSE
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ITM Solucin GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
GastroEnteroPancreatic, non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peptide Receptor Radionuclide Therapy (PRRT) Arm
Arm Type
Experimental
Arm Title
CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Other Intervention Name(s)
177Lu-DOTATOC 177Lu-Edo
Intervention Description
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
Intervention Type
Drug
Intervention Name(s)
CAPTEM (Capecitabine and Temozolomide)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Amino-Acid Solution
Other Intervention Name(s)
Arginine-Lysine Solution
Intervention Description
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS (Overall Survival), defined as the time from randomization until death;
Time Frame
Up to 2 years after disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Schneider, Dr
Email
info-solucin@itm-radiopharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Rotger, Dr
Email
info-solucin@itm-radiopharma.com
Facility Information:
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carina Aparici
Email
drmari@stanford.edu
Facility Name
University of Colorado Hospital, Nuclear Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bennett Chin
Phone
720-848-1213
Email
BENNETT.CHIN@CUANSCHUTZ.EDU
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Strosberg
Phone
813-745-6392
Email
jonathan.strosberg@moffitt.org
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Perez
Phone
617-632-6492
Email
kimberly_perez@dfci.harvard.edu
Facility Name
Mayo Clinic - Rochester, Department of Oncology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorvardur Halfdanarson
Phone
319-353-8775
Email
Halfdanarson.Thorvardur@mayo.edu
Facility Name
Washington University Alvin J. Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Wahl
Email
rwahl@wustl.edu
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nithya Raj, MD
Phone
646-888-4849
Email
rajn@mskcc.org
Facility Name
Duke University School of Medicine, Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Morse
Phone
919-668-1861
Email
michael.morse@duke.edu
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Pegna
Email
pegna@ohsu.edu
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Namrata Vijayvergia
Phone
215-214-1676
Email
namrata.vijayvergia@fccc.edu
Facility Name
Scott Paulson
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Paulson, M.D.
Email
scott.paulson@usoncology.com
First Name & Middle Initial & Last Name & Degree
Scott Paulson, M.D.
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Halperin, MD
Phone
713-792-2828
Email
dmhalperin@mdanderson.org
Facility Name
University of Utah, Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heloisa Soares
Phone
801-585-0255
Email
Heloisa.Soares@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Heloisa Soares
Facility Name
Royal North Shore Hospital
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Chan
Phone
+61 (422) 162 623
Email
david.chan@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
David Chan
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
VIC 3000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Michael
Facility Name
Haut-Leveque Hospital, Department of Hepatogastroenterology and Digestive Tract Oncology
City
Pessac
State/Province
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Smith
Phone
+33 (055) 765 6439
Email
denis.smith@chu-bordeaux.fr
Facility Name
Nantes University Hospital Center - Hotel Dieu Hospital
City
Nantes
State/Province
Cedex
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Ansquer
Phone
+33 (2) 40 08 41 36
Email
catherine.ansquer@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Catherine Ansquer
Facility Name
Edouard Herriot Hospital, Medical Oncology Unit
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Walter
Phone
+33 (4) 72 11 00 94
Email
thomas.walter@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Thomas Walter
Facility Name
IUCT Oncopole - Institut Universitaire du Cancer de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dierickx Lawrence, MD
Phone
+5 (31) 155 629
Email
dierickx.lawrence@iuct-oncopole.fr
Facility Name
Charite - University Hospital Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Jann
Phone
+4930450553032
Email
henning.jann@charite.de
Facility Name
University Hospital Bonn, Department of Nuclear Medicine
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Essler
Phone
+49 (228) 28715181
Email
Markus.Essler@ukbonn.de
First Name & Middle Initial & Last Name & Degree
Markus Essler
Facility Name
University Hospital Erlangen, Department of Internal Medicine I - Endocrinology
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Pavel
Phone
+49 (9131) 853 4651
Email
Marianne.Pavel@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Marianne Pavel
Facility Name
University Duisburg-Essen, University Hospital Essen, Clinic for Nuclear Medicine
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Herrmann
Phone
+49 (201) 723 2032
Email
ken.herrmann@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Ken Herrmann
Facility Name
All India Institute Of Medical Sciences, Nuclear Medicine
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chandrashekar Bal
First Name & Middle Initial & Last Name & Degree
Chandrashekar Bal
Facility Name
HCG Cancer Centre, Medical Oncology
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
K. Govind Babu, MD
Phone
+919845072940
Email
kgblaugh@gmail.com
Facility Name
Tata Memorial Hospital, Nuclear Medicine & Molecular Imaging
City
Mumbai
ZIP/Postal Code
400012
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venkatesh Rangarajan
Facility Name
University Polyclinic Hospital "G. Martino", Department of Biomedical Sciences, Dentistry and Morphological and Functional Imaging, Complex Operational Unit of Nuclear Medicine
City
Messina
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Baldari
Phone
+39 (090) 221 2840
Email
sergio.baldari@unime.it
Facility Name
European Institute of Oncology (IEO), IRCCS
City
Milan
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Fazio
Email
nicola.fazio@ieo.it
Facility Name
University Hospital "Federico II", Department of Molecular and Clinical Endocrinology and Oncology
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Giuliano
Phone
+39 (081) 746 3772
Email
m.giuliano@unina.it
Facility Name
University Polyclinic Foundation "Agostino Gemelli" - IRCCS, Complex Operative Unit of Medical Oncology
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Schinzari
Phone
+39 (06) 30156318
Email
giovanni.schinzari@policlinicogemelli.it
First Name & Middle Initial & Last Name & Degree
Giovanni Schinzari
Facility Name
VU Medical Center (VUMC), Department of Medical Oncology
City
Amsterdam
ZIP/Postal Code
1081-HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Kluempen
Phone
+31 (20) 444 4321
Email
h.klumpen@amsterdamumc.nl
Facility Name
University Hospital Vall d'Hebron, Department of Medical Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaume Capdevila
Phone
+34 (93) 274 6085
Email
jacapdevila@vhebron.net
Facility Name
ICO Hospitalet, Catalan Institute of Oncology
City
Barcelona
ZIP/Postal Code
199-203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Vega
Phone
+34 (932) 607 957
Email
ateule@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Alexandre Vega
Facility Name
University Hospital 12 de Octubre, Department of Gastroenterology
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Garcia Carbonero
Phone
+34 (955) 013 068
Email
rgcarbonero@gmail.com
First Name & Middle Initial & Last Name & Degree
Rocio Garcia Carbonero
Facility Name
Central University Hospital de Asturias (HUCA), IUOPA - Universitary Institute of Oncology
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Fonseca
Phone
+34 (985) 106 121
Email
palucaji@hotmail.com
First Name & Middle Initial & Last Name & Degree
Paula Fonseca
Facility Name
University Hospital Complex of Santiago (CHUS)
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Pubul
Phone
+34 (981) 950 000
Email
virginia.pubul.nunez@sergas.es;
First Name & Middle Initial & Last Name & Degree
Virginia Pubul
Facility Name
University and Polytechnic Hospital La Fe, Endocrinology
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Segura
Phone
+34 (722) 109 170
Email
segura_ang@gva.es
Facility Name
Uppsala University Hospital, Department of Oncology
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Individual Site Status
Withdrawn
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajaventhan Srirajaskanthan
Phone
+44 (02032) 993 854
Email
r.srirajaskanthan@nhs.net

12. IPD Sharing Statement

Learn more about this trial

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE

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