Clinical Trial: Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First Randomized Phase II

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Antitumor Efficacy of Peptide Receptor Radionuclide Therapy With 177Lutetium -Octreotate Randomized vs Sunitinib in Unresectable Progressive Well-differentiated Neuroendocrine Pancreatic Tumor: First

Brief Summary: This study is the first randomized, open-label, national, multicenter, phase II study assessing the efficacy and safety of OCLU in subjects with pretreated progressive pancreatic, inoperable, somatostatin receptor positive, well differentiated pancreatic neuroendocrine tumors (WDpNET). Subjects must have experienced documented progression of disease within 1 year prior to the start of the study. The control group of patients receiving Sutent will be used as internal control to assess the hypothesis of 12 months PFS equal to 35% in patients receiving Sutent.

Detailed Summary:
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Current Primary Outcome: To determine the 12 months PFS [ Time Frame: Assessed 12 months after randomization ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Overall Survival [ Time Frame: Assessed every 3 months until death ]
• Best response [ Time Frame: Assessed every 12 weeks until progression up to 48 months ]
  According to RECIST V1.1

Original Secondary Outcome: Same as current

Information By: Gustave Roussy, Cancer Campus, Grand Paris

Dates:
Date Received: August 27, 2014
Date Started: February 2015
Date Completion: October 2023
Last Updated: July 11, 2016
Last Verified: July 2016