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

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: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
• Intervention / Treatment: Drug: sunitinib; Drug: everolimus; Drug: chemotherapies recommended in france

Detailed Description

prospective and retrospective Analyses will be performed using SAS® software

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU d'Amiens
  • Angers, France, 49100
    • CHU d'Angers
  • Bordeaux, France, 33000
    • Hôpital Saint-André
  • Caen, France, 14000
    • CHU de CAEN
  • Challes Les Eaux, France, 73190
    • Cabinet Médical
  • Chambray-lès-Tours, France, 37170
    • CHRU de Tours - Hôpital Trousseau
  • Clermont Ferrand Cedex, France, 63003
    • Hôpital d'Estaing
  • Dijon Cedex, France, 21079
    • Hôpital 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
    • Hôpital Haut Lévêque
  • 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

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

How is the study designed?

Number of groups / cohorts

3

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	at baseline, each 3 to 4 months up to 2 years
Overall survival	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	at baseline, each 3 to 4 months up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Novartis; Keyrus Biopharma

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

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: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Neuroendocrine Tumors; Adenoma, Islet Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib; Everolimus
• 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.