OPALINE : A Study Of Morbidity And Mortality At 2 Years (OPALINE)

December 30, 2019 updated by: Pfizer

AN OBSERVATIONAL REAL-WORLD STUDY OF THE SYSTEMIC TREATMENT OF WELL-DIFFERENTIATED, UNRESECTABLE OR METASTATIC, PROGRESSIVE PANCREATIC NEUROENDOCRINE TUMOURS (PNET): A STUDY OF MORBIDITY AND MORTALITY AT 2 YEARS

A descriptive, prospective (partly retrospective), multisite, observational study conducted in France in adult patients treated for a well differentiated, unresectable or metastatic, pancreatic neuroendocrine tumor with disease progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

prospective and retrospective Analyses will be performed using SAS® software

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU d'AMIENS
      • Angers, France, 49100
        • CHU d'Angers
      • Bordeaux, France, 33000
        • Hopital Saint-Andre
      • Caen, France, 14000
        • CHU de Caen
      • Challes Les Eaux, France, 73190
        • Cabinet Médical
      • Chambray-lès-Tours, France, 37170
        • CHRU de Tours - Hopital Trousseau
      • Clermont Ferrand Cedex, France, 63003
        • Hôpital d'Estaing
      • Dijon Cedex, France, 21079
        • Hopital Du Bocage
      • Grenoble, France, 38043
        • Unite d'Oncologie Digestive, Departement d'HGE
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Limoges, France, 87000
        • Chu Dupuytren Service Oncologie
      • Lorient, France, 56100
        • CH Bretagne Sud
      • Lyon, France, 69437
        • Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive
      • Lyon, France, 69437
        • Hopital Edouard Herriot, Pavillion O, Oncologie Medicale
      • Lyon Cedex 3, France, 69437
        • Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H
      • Marseille, France, 13005
        • Hopital La Timone Service de Gastroenterologie et Oncologie Digestive
      • Metz Tessy, France, 74370
        • CHR d'Annecy
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Montpellier, France, 34298
        • Centre Val D'Aurelle-Paul Lamarque
      • Orleans CEDEX 2, France, 45067
        • Hopital de LA Source, Centre Hospitalier Regional
      • Paris, France, 75014
        • Hôpital COCHIN
      • Paris, France, 75013
        • CH Pitie Salpetriere
      • Paris Cedex, France, 75679
        • Groupe Hospitalier Cochin
      • Perpignan Cedex, France, 66046
        • Hopital Saint Jean
      • Pessac, France, 33600
        • Hopital Haut Leveque
      • Quimper Cedex, France, 29107
        • Hopital de Cornouaille
      • Reims CEDEX, France, 51092
        • Hopital Robert Debre, Service D'Hepato-gastro-enterolo
      • Reims cedex, France, 51092
        • C.H.U. de Reims - Hôpital Robert Debré
      • Saint Brieuc, France
        • Clinique Armoricaine
      • Saint-Nazaire, France, 44600
        • Pôle Hospitalier Mutualiste
      • Saint-Nazaire Cedex, France, 44606
        • Clinique Mutualiste de l'Estuaire
      • Strasbourg Cedex, France, 67098
        • CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition
      • Suresnes cedex, France, 92151
        • Hopital Foch, Onco Hermatologie
      • Vannes, France, 56000
        • Cabinet Médical
      • Villejuif, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with progressive, metastatic or unresectable, and well differentiated pancreatic neuroendocrine tumors

Description

Inclusion Criteria:

  • Patients over 18 years of age;

  • 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 with a diagnosis of poorly differentiated neuroendocrine carcinoma or an adenoneuroendocrine carcinoma.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sunitinib
Drug: sunitinib
sunitinib 37.5mg/d orally
Afinitor
Drug: everolimus
everolimus 10mg/d orally
other treatment (chémotherapy, SSA..)
Drug: chemotherapies recommended in france
depends on the chemotherapy prescribed (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival
Time Frame: at baseline, each 3 to 4 months up to 2 years
at baseline, each 3 to 4 months up to 2 years
Overall survival
Time Frame: at baseline, each 3 to 4 months up to 2 years
at baseline, each 3 to 4 months up to 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: at baseline, each 3 to 4 months up to 2 years
at baseline, each 3 to 4 months up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient demographic characteristics
Time Frame: baseline
baseline
number of subjects using targeted therapy at baseline
Time Frame: Baseline
Baseline
Change from baseline in treatment therapy received
Time Frame: approximately every 3 months up to 2 years
approximately every 3 months up to 2 years
number of subjects using therapy other than targeted at baseline
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Novartis
Keyrus Biopharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2015

Primary Completion (Actual)

November 18, 2019

Study Completion (Actual)

November 18, 2019

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181214
  • OPALINE (Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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