OPALINE : A Study Of Morbidity And Mortality At 2 Years
NCT ID: NCT02264665
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
144 participants
OBSERVATIONAL
2015-05-12
2019-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Sunitinib
sunitinib
sunitinib 37.5mg/d orally
Afinitor
everolimus
everolimus 10mg/d orally
other treatment (chémotherapy, SSA..)
chemotherapies recommended in france
depends on the chemotherapy prescribed (IV)
Interventions
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sunitinib
sunitinib 37.5mg/d orally
everolimus
everolimus 10mg/d orally
chemotherapies recommended in france
depends on the chemotherapy prescribed (IV)
Eligibility Criteria
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Inclusion Criteria
* Patients treated with a targeted therapy (sunitinib, everolimus) or with other treatments (interferon, or metabolic radiotherapy, or chemotherapy or somatostatin analog)\* for:
\*Patients whose treatment line (targeted therapy or other treatment) is initiated as a 1st, 2nd, 3rd or 4th line of therapy at the time of inclusion (incident patients) or patients receiving their 1st, 2nd, 3rd or 4th line of therapy provided that treatment was initiated in the site in which the patient is enrolled in the study (prevalent patients); a change of line is defined as a change in molecule or combination.
* A histologically confirmed unresectable or metastatic pancreatic neuroendocrine tumor;
* Well-differentiated;
* Progressive prior to initiation of treatment in the investigator's judgment (clinical or radiological progression);
* Patients who have been informed of the conditions of the study and who have signed the informed consent.
Exclusion Criteria
* Patients receiving targeted therapy (everolimus or sunitinib) already received in a previous line of treatment (rechallenged patient).
* Patients refusing to give consent.
* Patients receiving a fifth line or subsequent line of systemic treatment.
* Patients participating in a clinical trial in a treatment arm not validated by the MA and the TNCD according to the version dated December 2013.
* Patients randomized to the placebo arm of a placebo-controlled trial or to a double-blind trial.
18 Years
99 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Keyrus Biopharma
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Hopital Saint-Andre
Bordeaux, , France
CHU de Caen
Caen, , France
Cabinet Medical
Challes-les-Eaux, , France
CHRU de Tours - Hôpital TROUSSEAU
Chambray-lès-Tours, , France
Hopital d'Estaing
Clermont-Ferrand, , France
Hopital du Bocage
Dijon, , France
Unite d'Oncologie Digestive, Departement d'HGE
Grenoble, , France
Centre Oscar Lambret
Lille, , France
Chu Dupuytren Service Oncologie
Limoges, , France
CH Bretagne Sud
Lorient, , France
Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive
Lyon, , France
Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H
Lyon, , France
Hopital Edouard Herriot, Pavillion O, Oncologie Medicale
Lyon, , France
Hopital La Timone Service de Gastroenterologie et Oncologie Digestive
Marseille, , France
CHR d'Annecy
Metz-Tessy, , France
Centre Val D'Aurelle-Paul Lamarque
Montpellier, , France
CRLC Val d'Aurelle
Montpellier, , France
Hopital de LA Source, Centre Hospitalier Regional
Orléans, , France
CH Pitie Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
Groupe Hospitalier Cochin
Paris, , France
Hopital Saint Jean
Perpignan, , France
Hôpital Haut Lévèque
Pessac, , France
Hopital de Cornouaille
Quimper, , France
C.H.U. de Reims - Hôpital Robert Debré
Reims, , France
Hopital Robert Debre, Service D'Hepato-gastro-enterolo
Reims, , France
Clinique Armoricaine
Saint-Brieuc, , France
Pôle Hospitalier Mutualiste
Saint-Nazaire, , France
Clinique Mutualiste de l'estuaire
Saint-Nazaire, , France
CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition
Strasbourg, , France
Hopital Foch, Onco Hermatologie
Suresnes, , France
Cabinet Medical
Vannes, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Smith D, Lepage C, Vicaut E, Dominguez S, Coriat R, Dubreuil O, Lecomte T, Baudin E, Venat Bouvet L, Samalin E, Santos A, Borie O, Bisot-Locard S, Goichot B, Lombard-Bohas C. Observational Study in a Real-World Setting of Targeted Therapy in the Systemic Treatment of Progressive Unresectable or Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors (pNETs) in France: OPALINE Study. Adv Ther. 2022 Jun;39(6):2731-2748. doi: 10.1007/s12325-022-02103-7. Epub 2022 Apr 13.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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OPALINE
Identifier Type: OTHER
Identifier Source: secondary_id
A6181214
Identifier Type: -
Identifier Source: org_study_id
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