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Sequentiality of Everolimus and STZ-5FU in Advanced Pancreatic Neuroendocrine Tumor

NCT02246127 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2025-05-11

Study results available
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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.

Conditions

Interventions

DRUG

Drug: Everolimus

10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops.

DRUG

STZ-5FU

0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala). Number of Cycles: until progression or unacceptable toxicity develops.

Sponsors & Collaborators

  • European Neuroendocrine Tumor Society

    collaborator UNKNOWN

  • Kantar Health

    collaborator INDUSTRY

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Grupo Espanol de Tumores Neuroendocrinos

    lead OTHER

Principal Investigators

  • Salazar Ramon, MD, PhD · Instituto Catalán de Oncologia, ICO-Hospitalet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
94 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-27
Primary Completion
2020-11-18
Completion
2021-07-12

Countries

  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02246127 on ClinicalTrials.gov