Observational Study In Real Life Settings Of The Systemic Treatment Of Well Differentiated, Unresectable Or Metastatic, Progressive Pancreatic Neuroendocrine Tumors (pNET): A Study Of Morbidity And Mortality At 2 Years
Conditions
Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive
Conditions: official terms
Adenoma, Islet Cell - Apudoma - Carcinoid Tumor - Neuroendocrine Tumors
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort
Intervention
Name: sunitinib Type: Drug
Name: everolimus Type: Drug
Name: chemotherapies recommended in france Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Centre Oscar Lambret
Lille, France
Status: Recruiting
Chu Dupuytren Service Oncologie
Limoges, France
Status: Recruiting
Hôpital La Timone
Marseille, France
Status: Recruiting
Clinique Armoricaine de Radiologie
Saint Brieuc, France
Status: Recruiting
Start Date
May 2015
Completion Date
June 2019
Sponsors
Pfizer
Source
Pfizer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page