OPALINE : A Study Of Morbidity And Mortality At 2 Years

• Status: Completed
• Trial end date: 2019-11-18
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: Keyrus; Keyrus Biopharma; Novartis
• Treatments: Everolimus; Sirolimus; Sunitinib

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.