Clinical trial · Observational
OPALINE : A Study Of Morbidity And Mortality At 2 Years
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
NCT02264665CI-TRIAL-00071277OPALINEcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neuroendocrine Tumor, Well Differentiated and Progressive | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapies recommended in france | Drug | — | UNRESOLVED |
| everolimus | Drug | Everolimus | ALIAS |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- label
- Sunitinib
- interventionNames
- Drug: sunitinib
- label
- Afinitor
- interventionNames
- Drug: everolimus
- label
- other treatment (chémotherapy, SSA..)
- interventionNames
- Drug: chemotherapies recommended in france
Primary outcomes (8)
- measure
- 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
- timeFrame
- At 2 years of prospective follow-up
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSmith 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