Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor (NCT02246127) | Clinical Trial Compass
CompletedPhase 3
Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor
Denmark, France141 participantsStarted 2014-10-27
Plain-language summary
The purpose of this study is to compare streptozotocin (STZ) vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of STZ based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.
Who can participate
Age range18 Years – 94 Years
SexALL
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Inclusion Criteria:
* Histologically proven diagnosis of unresectable or metastatic, advanced pancreatic NET.
* Documented confirmation of pancreatic NET G1 or G2 as per European Neuroendocrine Society (ENETS) classification system.
* Patients from whom a paraffin-embedded primary tumour or metastasis block is available and to be sent by Courier.
* Before study inclusion, patients must show progressive disease documented by radiology 12 months prior to study inclusion. Treatment naive patients can be also included if the patient needs active treatment with either chemotherapy or everolimus.
* Presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0, documented by a Triphasic Computed Tomography (CT) scan or multiphase MRI radiological assessment.
* Previous treatment with somatostatin (SS) analogues is allowed. Only those patients with active functioning syndrome at entry can continue with SS analogues during the study.
* Adequate bone marrow and renal functions, and serum fasting cholesterol
* Women with child-bearing potential must have a negative serum pregnancy test.
* Written Informed Consent obtained according to local regulations
Exclusion Criteria:
* Previous treatment with chemotherapy and/or mTOR inhibitors or tyrosine kinase inhibitors.
* Immune therapy or radiation therapy within 4 weeks prior to the patient entering the study.
* Hepatic artery embolization within the last 6 months (1 month if there are other site…