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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

Outcome Description:

Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.

Outcome Time Frame:

Up to 7 years

Safety Issue:

No

Principal Investigator

Rudolf Arnold, MD, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Philipps University Marburg Medical Center

Authority:

European Union: European Medicines Agency

Study ID:

CSMS995ADE05

NCT ID:

NCT00171873

Start Date:

September 2001

Completion Date:

December 2013

Related Keywords:

  • Neuroendocrine Tumors
  • Double blind
  • Phase III
  • Disease
  • Clinical trial
  • Octreotide
  • Neuroendocrine tumor
  • Cancer
  • Tumor
  • Midgut
  • Neoplasm Metastasis
  • Neuroendocrine Tumors

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