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Trial record 98 of 1297 for:    survival | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT02264665
Recruitment Status : Recruiting
First Posted : October 15, 2014
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
Novartis
Keyrus Biopharma
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive Drug: sunitinib Drug: everolimus Drug: chemotherapies recommended in france

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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : May 12, 2015
Estimated Primary Completion Date : September 18, 2019
Estimated Study Completion Date : September 18, 2019


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)




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
  2. Overall survival [ Time Frame: at baseline, each 3 to 4 months up to 2 years ]
  3. 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 ]

Secondary Outcome Measures :
  1. Patient demographic characteristics [ Time Frame: baseline ]
  2. number of subjects using targeted therapy at baseline [ Time Frame: Baseline ]
  3. Change from baseline in treatment therapy received [ Time Frame: approximately every 3 months up to 2 years ]
  4. number of subjects using therapy other than targeted at baseline [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with progressive, metastatic or unresectable, and well differentiated pancreatic neuroendocrine tumors
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264665


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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France
CHU d'Amiens Active, not recruiting
Amiens, France, 80054
CHU d'Angers Active, not recruiting
Angers, France, 49100
Hopital Saint-Andre Recruiting
Bordeaux, France, 33000
CHU de Caen Recruiting
Caen, France, 14000
Cabinet Medical Recruiting
Challes Les Eaux, France, 73190
CHRU de Tours - Hôpital TROUSSEAU Recruiting
Chambray-lès-Tours, France, 37170
Hopital d'Estaing Active, not recruiting
Clermont Ferrand Cedex, France, 63003
Hopital du Bocage Recruiting
Dijon Cedex, France, 21079
Unite d'Oncologie Digestive, Departement d'HGE Active, not recruiting
Grenoble, France, 38043
Centre Oscar Lambret Recruiting
Lille, France, 59020
Chu Dupuytren Service Oncologie Recruiting
Limoges, France, 87000
CH Bretagne Sud Active, not recruiting
Lorient, France, 56100
Hopital Edouard Herriot - Service d'Oncologie Digestive, Pavillon H Recruiting
Lyon Cedex 3, France, 69437
Hopital Edouard Herriot - Pavillon H - Service d'oncologie digestive Recruiting
Lyon, France, 69437
Hopital Edouard Herriot, Pavillion O, Oncologie Medicale Recruiting
Lyon, France, 69437
Hopital La Timone Service de Gastroenterologie et Oncologie Digestive Recruiting
Marseille, France, 13005
CHR d'Annecy Recruiting
Metz Tessy, France, 74370
Centre Val D'Aurelle-Paul Lamarque Active, not recruiting
Montpellier, France, 34298
CRLC Val d'Aurelle Recruiting
Montpellier, France, 34298
Hopital de LA Source, Centre Hospitalier Regional Recruiting
Orleans CEDEX 2, France, 45067
Groupe Hospitalier Cochin Active, not recruiting
Paris Cedex, France, 75679
CH Pitie Salpetriere Recruiting
Paris, France, 75013
Hopital Cochin Active, not recruiting
Paris, France, 75014
Hopital Saint Jean Active, not recruiting
Perpignan Cedex, France, 66046
Hôpital Haut Lévèque Recruiting
Pessac, France, 33600
Hopital de Cornouaille Active, not recruiting
Quimper Cedex, France, 29107
C.H.U. de Reims - Hôpital Robert Debré Active, not recruiting
Reims cedex, France, 51092
Hopital Robert Debre, Service D'Hepato-gastro-enterolo Recruiting
Reims CEDEX, France, 51092
Clinique Armoricaine Active, not recruiting
Saint Brieuc, France
Clinique Mutualiste de l'estuaire Active, not recruiting
Saint-Nazaire Cedex, France, 44606
Pôle Hospitalier Mutualiste Recruiting
Saint-Nazaire, France, 44600
CHU de Strasbourg - Hopital de Hautepierre / Service de Medecine Interne et Nutrition Recruiting
Strasbourg Cedex, France, 67098
Hopital Foch, Onco Hermatologie Active, not recruiting
Suresnes cedex, France, 92151
Cabinet Medical Active, not recruiting
Vannes, France, 56000
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Sponsors and Collaborators
Pfizer
Novartis
Keyrus Biopharma
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02264665     History of Changes
Other Study ID Numbers: A6181214
OPALINE ( Other Identifier: Alias Study Number )
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Adenoma, Islet Cell
Adenoma
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Everolimus
Sirolimus
Sunitinib
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances