OPALINE : A Study Of Morbidity And Mortality At 2 Years
- Conditions
- Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
- Interventions
- Registration Number
- NCT02264665
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
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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;
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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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description other treatment (chémotherapy, SSA..) chemotherapies recommended in france - Sunitinib sunitinib - Afinitor everolimus -
- Primary Outcome Measures
Name Time Method 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 At 2 years of prospective follow-up 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.
Number of Participants With Adverse Events Leading to Discontinuation of Treatment - Based on Treatment Received At-least Once During the Study During 2 years of prospective follow-up 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.
PFS at 2 Years Assessed by Investigator Per RECIST v1.1 - Based on Targeted Therapy Group and Other Treatments Group at Inclusion At 2 years of prospective follow-up 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.
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 Overall Survival (OS) Rate at 2 Years - Based on Type of Treatment at Inclusion At 2 years of prospective follow-up 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.
OS Rate at 2 Years- Based on Targeted Therapy Group and Other Treatments Group at Inclusion At 2 years of prospective follow-up 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.
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 During 2 years of prospective follow-up 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.
Number of Participants With Adverse Events Leading to Death - Based on Treatment Received At-least Once During the Study During 2 years of prospective follow-up 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.
- Secondary Outcome Measures
Name Time Method 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 Frequency = number of tumor assessment visits /(\[last visit date - baseline date\]/365.25).
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 The different types of investigations were performed for assessment of tumor regardless of treatment received. Investigations performed were Computed Tomography (CT) scan, Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) scan, Octreoscan, Ultrasound. All the investigations were used at least once during the study for all treatments.
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 In this outcome measure, number of participants with a change in treatment compared to treatment at inclusion is reported.
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 Number of participants according to number of changes in doses of treatment is reported for this outcome measure.
Number of Main Lines of Treatment Received During the Study - Based on Targeted Therapy Group and Other Treatments Group at Inclusion During 2 years of prospective follow-up The number of main lines of treatment received during the study treatment are reported in this outcome measure.
Number of Participants According to Course of Changes in Doses of Treatment - Based on Type of Treatment (Metabolic Radiotherapy) at Inclusion During 2 years of prospective follow-up Number of participants according to course of changes in doses of treatment is reported for this outcome measure.
Number of Combined Main Lines of Treatments Received - Based on Targeted Therapy Group and Other Treatments Group at Inclusion During 2 years of prospective follow-up The number of lines of combined main treatment administered during the study were assessed.
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 During 2 years of prospective follow-up The types of main lines of treatment included 1st line, 2nd line, 3rd line, 4th line, 5th line, 6th line, 7th line and 8th line.
Trial Locations
- Locations (34)
Groupe Hospitalier Cochin
🇫🇷Paris Cedex, France
CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition
🇫🇷Strasbourg Cedex, France
Hopital Foch, Onco Hermatologie
🇫🇷Suresnes cedex, France
Hopital Saint-Andre
🇫🇷Bordeaux, France
Hopital de LA Source, Centre Hospitalier Regional
🇫🇷Orleans CEDEX 2, France
Hopital du Bocage
🇫🇷Dijon Cedex, France
Centre Val D'Aurelle-Paul Lamarque
🇫🇷Montpellier, France
CRLC Val d'Aurelle
🇫🇷Montpellier, France
CHU d'Angers
🇫🇷Angers, France
CHU de Caen
🇫🇷Caen, France
Institut Gustave Roussy
🇫🇷Villejuif, France
CHU d'Amiens
🇫🇷Amiens, France
Cabinet Medical
🇫🇷Vannes, France
Hopital d'Estaing
🇫🇷Clermont Ferrand Cedex, France
CHRU de Tours - Hôpital TROUSSEAU
🇫🇷Chambray-lès-Tours, France
Unite d'Oncologie Digestive, Departement d'HGE
🇫🇷Grenoble, France
Chu Dupuytren Service Oncologie
🇫🇷Limoges, France
CH Bretagne Sud
🇫🇷Lorient, France
Centre Oscar Lambret
🇫🇷Lille, France
Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H
🇫🇷Lyon Cedex 3, France
CHR d'Annecy
🇫🇷Metz Tessy, France
Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive
🇫🇷Lyon, France
Hopital Edouard Herriot, Pavillion O, Oncologie Medicale
🇫🇷Lyon, France
Hopital La Timone Service de Gastroenterologie et Oncologie Digestive
🇫🇷Marseille, France
Hopital Saint Jean
🇫🇷Perpignan Cedex, France
Hôpital Haut Lévèque
🇫🇷Pessac, France
CH Pitie Salpetriere
🇫🇷Paris, France
Hopital de Cornouaille
🇫🇷Quimper Cedex, France
C.H.U. de Reims - Hôpital Robert Debré
🇫🇷Reims cedex, France
Hopital Robert Debre, Service D'Hepato-gastro-enterolo
🇫🇷Reims CEDEX, France
Clinique Mutualiste de l'estuaire
🇫🇷Saint-Nazaire Cedex, France
Clinique Armoricaine
🇫🇷Saint Brieuc, France
Pôle Hospitalier Mutualiste
🇫🇷Saint-Nazaire, France
Hopital Cochin
🇫🇷Paris, France