Clinical trial NCT02264665: OPALINE : A Study Of Morbidity And Mortality At 2 Years
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Novartis
name: Keyrus Biopharma
First posted: 2014-10-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with progressive, metastatic or unresectable, and well differentiated pancreatic neuroendocrine tumors

Brief summary: 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.

Detailed description: prospective and retrospective Analyses will be performed using SAS® software

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) at 2 Years Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 - Based on Type of Treatment at Inclusion
timeFrame: At 2 years of prospective follow-up
measure: PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: At 2 years of prospective follow-up
measure: Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion
timeFrame: At 2 years of prospective follow-up
measure: OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: At 2 years of prospective follow-up
measure: Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Related AEs, SAEs and SAEs With Common Terminology Criteria For Adverse Events (CTCAE) 3, 4 and 5, v4.0-Based on Treatment Received At-least Once During Study
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study
timeFrame: During 2 years of prospective follow-up
Secondary outcomes:
measure: Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants According to Number of Changes in Doses of Treatment - Based on Type of Treatment (Everolimus, Sunitinib, Chemotherapy and Somatostatin Analogues) at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
measure: Number of Participants With Types of Main Lines of Treatment Received During the Follow-up - Based on Targeted Therapy Group and Other Treatments Group at Inclusion
timeFrame: During 2 years of prospective follow-up
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Caen
country: France
facility: CHU de Caen
city: Challes Les Eaux
country: France
facility: Cabinet Medical
city: Chambray-lès-Tours
country: France
facility: CHRU de Tours - Hôpital TROUSSEAU
city: Clermont Ferrand Cedex
country: France
facility: Hopital d'Estaing
city: Dijon Cedex
country: France
facility: Hopital du Bocage
city: Grenoble
country: France
facility: Unite d'Oncologie Digestive, Departement d'HGE
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Chu Dupuytren Service Oncologie
city: Lorient
country: France
facility: CH Bretagne Sud
city: Lyon Cedex 3
country: France
facility: Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H
city: Lyon
country: France
facility: Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive
city: Lyon
country: France
facility: Hopital Edouard Herriot, Pavillion O, Oncologie Medicale
city: Marseille
country: France
facility: Hopital La Timone Service de Gastroenterologie et Oncologie Digestive
city: Metz Tessy
country: France
facility: CHR d'Annecy
city: Montpellier
country: France
facility: Centre Val D'Aurelle-Paul Lamarque
city: Montpellier
country: France
facility: CRLC Val d'Aurelle
city: Orleans CEDEX 2
country: France
facility: Hopital de LA Source, Centre Hospitalier Regional
city: Paris Cedex
country: France
facility: Groupe Hospitalier Cochin
city: Paris
country: France
facility: CH Pitie Salpetriere
city: Paris
country: France
facility: Hopital Cochin
city: Perpignan Cedex
country: France
facility: Hopital Saint Jean
city: Pessac
country: France
facility: Hôpital Haut Lévèque
city: Quimper Cedex
country: France
facility: Hopital de Cornouaille
city: Reims cedex
country: France
facility: C.H.U. de Reims - Hôpital Robert Debré
city: Reims CEDEX
country: France
facility: Hopital Robert Debre, Service D'Hepato-gastro-enterolo
city: Saint Brieuc
country: France
facility: Clinique Armoricaine
city: Saint-Nazaire Cedex
country: France
facility: Clinique Mutualiste de l'estuaire
city: Saint-Nazaire
country: France
facility: Pôle Hospitalier Mutualiste
city: Strasbourg Cedex
country: France
facility: CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition
city: Suresnes cedex
country: France
facility: Hopital Foch, Onco Hermatologie
city: Vannes
country: France
facility: Cabinet Medical
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.