Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carmen Schade-Brittinger
• Treatments: Octreotide

Criteria

Inclusion Criteria:

• Therapy-naive patients with histologically confirmed diagnosis of a locally inoperable or metastasized well-differentiated neuroendocrine tumor of the midgut

• curative surgery impossible

• two-dimensional tumor formation assessable by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

• Age ≥ 18

• Karnofsky-index > 60

• written informed consent

• proliferation index for Ki67

Exclusion Criteria:

• hypersensitivity to octreotide

• poorly differentiated or small cell neuroendocrine tumors

• primary tumor outside of the midgut

• prior treatment with somatostatin-analogue > 4 weeks

• prior treatment with alpha-interferon, chemotherapy, or chemoembolisation

• participation in any other clinical trial

• pregnancy or lactation

• no secondary malignancy in anamnesis; with the exception of patients without any manifestation of the secondary malignancy (without relapse) after curative therapy within the last five years

• severe decompensated organ malfunction (heart-, liver- insufficiency)

Other protocol-defined exclusion criteria may apply.