Status:
COMPLETED
Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Lead Sponsor:
Carmen Schade-Brittinger
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Placebo-controlled prospective randomized phase III study to investigate the antiproliferative effect of octreotide in patients with metastasized neuroendocrine tumors of the midgut
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00171873
Start Date
September 1 2001
End Date
December 1 2013
Last Update
March 26 2020
Active Locations (10)
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1
Novartis Investigative Site
Bochum, Germany
2
Novartis Investigative Site
Dresden, Germany
3
Novartis Investigative Site
Halle, Germany
4
Novartis Investigative Site
Hamburg, Germany