OPALINE : A Study Of Morbidity And Mortality At 2 Years

NCT02264665 | Completed Results

• 2 other identifiers: A6181214OPALINE
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 35

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.

Conditions

Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive

Outcome Measures

Primary Outcomes (8)

• 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

  PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of disease progression (PD) or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.

  At 2 years of prospective follow-up

• PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  PFS was defined as time (in months) from date of start of treatment (the treatment line ongoing at the time of inclusion in the study) to first documentation of PD or date of death due to any cause, when receiving the main treatment at the time of inclusion. RECIST v1.1, PD: at least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment (this included baseline sum if that is smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. Appearance of 1 or more new target or non-target lesions. If a participant did not have an event, data censoring was done at the last recorded time to PD or the last tumor assessment, last disease assessment. Analysis was performed using Kaplan-Meier method.

  At 2 years of prospective follow-up

• Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion

  OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.

  At 2 years of prospective follow-up

• OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  OS was the percentage of participants who were alive at 2 years of prospective follow-up. OS was defined as the time (in months) from the date of start of treatment (of the treatment line ongoing at the time of inclusion in the study) to the date of death due to any cause. Participants with no event or lost to follow-up or alive at the end of the study were censored at their last follow-up date (last follow-up date or last news). Analysis was performed using Kaplan-Meier method.

  At 2 years of prospective follow-up

• Number of Participants With Reasons for Temporary and Permanent Treatment Discontinuation - Based on Targeted Therapy Group and Other Treatment Group at Inclusion

  During 2 years of prospective follow-up

• 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

  AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that: led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. Relatedness to treatment was assessed by investigator. Per CTCAE 4.0, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4=Life-threatening events Grade 5 (Death) events=death related to an AE. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

  During 2 years of prospective follow-up

• Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

  During 2 years of prospective follow-up

• Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events leading to death are reported in this outcome measure. Participants in this outcome measure were grouped according to type of treatment received at least once during study irrespective of treatment they initiated or were receiving at time of inclusion.

  During 2 years of prospective follow-up

Secondary Outcomes (9)

• Mean of Number of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  During 2 years of prospective follow-up

• Number of Participants According to Frequency of Tumor Assessment Visits - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  During 2 years of prospective follow-up

• Number of Participants With Different Types of Investigation Used for Tumor Assessment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  During 2 years of prospective follow-up

• Number of Participants Who Had a Change in Their Treatment - Based on Targeted Therapy Group and Other Treatments Group at Inclusion

  During 2 years of prospective follow-up

• 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

  During 2 years of prospective follow-up

Study Arms (3)

Sunitinib

Drug: sunitinib

Afinitor

Drug: everolimus

other treatment (chémotherapy, SSA..)

Drug: chemotherapies recommended in france

Interventions

sunitinib DRUG

sunitinib 37.5mg/d orally

Sunitinib

everolimus DRUG

everolimus 10mg/d orally

Afinitor

chemotherapies recommended in france DRUG

depends on the chemotherapy prescribed (IV)

other treatment (chémotherapy, SSA..)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead
• Novartis: collaborator
• Keyrus Biopharma: collaborator

Study Sites (35)

CHU d'Amiens

Amiens, 80054, France

Location

CHU d'Angers

Angers, 49100, France

Location

Hopital Saint-Andre

Bordeaux, 33000, France

Location

CHU de Caen

Caen, 14000, France

Location

Cabinet Medical

Challes-les-Eaux, 73190, France

Location

CHRU de Tours - Hôpital TROUSSEAU

Chambray-lès-Tours, 37170, France

Location

Hopital d'Estaing

Clermont-Ferrand, 63003, France

Location

Hopital du Bocage

Dijon, 21079, France

Location

Unite d'Oncologie Digestive, Departement d'HGE

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Chu Dupuytren Service Oncologie

Limoges, 87000, France

Location

CH Bretagne Sud

Lorient, 56100, France

Location

Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive

Lyon, 69437, France

Location

Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H

Lyon, 69437, France

Location

Hopital Edouard Herriot, Pavillion O, Oncologie Medicale

Lyon, 69437, France

Location

Hopital La Timone Service de Gastroenterologie et Oncologie Digestive

Marseille, 13005, France

Location

CHR d'Annecy

Metz-Tessy, 74370, France

Location

Centre Val D'Aurelle-Paul Lamarque

Montpellier, 34298, France

Location

CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Hopital de LA Source, Centre Hospitalier Regional

Orléans, 45067, France

Location

CH Pitie Salpetriere

Paris, 75013, France

Location

Hopital Cochin

Paris, 75014, France

Location

Groupe Hospitalier Cochin

Paris, 75679, France

Location

Hopital Saint Jean

Perpignan, 66046, France

Location

Hôpital Haut Lévèque

Pessac, 33600, France

Location

Hopital de Cornouaille

Quimper, 29107, France

Location

C.H.U. de Reims - Hôpital Robert Debré

Reims, 51092, France

Location

Hopital Robert Debre, Service D'Hepato-gastro-enterolo

Reims, 51092, France

Location

Clinique Armoricaine

Saint-Brieuc, France

Location

Pôle Hospitalier Mutualiste

Saint-Nazaire, 44600, France

Location

Clinique Mutualiste de l'estuaire

Saint-Nazaire, 44606, France

Location

CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition

Strasbourg, 67098, France

Location

Hopital Foch, Onco Hermatologie

Suresnes, 92151, France

Location

Cabinet Medical

Vannes, 56000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Related Publications (1)

• 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.

  PMID: 35419649 DERIVED

Related Links

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

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

Sunitinib; Everolimus

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: October 15, 2014
• Study Start: May 12, 2015
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (35)