Carcinoid Tumors After Failure of Somatostatin Analogs: a Randomized Phase III of Octreotide Lutate Peptid Receptor Radionuclide Therapy (PRRT) Versus Interferon α-2b (CASTOR)

NCT01860742 Phase 3 WITHDRAWN

The purpose of this study is to assess the benefit of 177Lu-DOTATATE versus interferon α-2b in patients with progressive, unresectable, non-pancreatic gastrointestinal neuroendocrine tumors resistant to therapy with somatostatin analogues, in terms of disease control.

Details

Lead sponsor	Jules Bordet Institute
Phase	Phase 3
Status	WITHDRAWN
Start date	2014-12
Completion	2016-10

Conditions

• Gastro-intestinal Neuroendocrine Tumors

Interventions

• Interferon alpha-2b
• 177Lu-DOTATATE

Primary outcomes

• Progression Free Survival (PFS) — 3 years [Anticipated]
  PFS is defined by the time between treatment initiation and the first of the following events: * Disease progression according to RECIST 1.1; * Death of the patient from any cause; * Appearance of confirmed new lesion(s) on 68Ga-DOTATATE PET/CT or 18FDG PET/CT.

Countries

Belgium