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NCT Number: NCT00171873

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

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

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Key information

Conditions

Neuroendocrine Tumors Disease Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Bochum, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Octreotide LAR (Long-acting release)

Drug

30 mg intramuscularly every 28 days

Other names: SMS995

Placebo

Drug

Sodium chloride intramuscularly every 28 days

Primary outcomes

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

    Time frame: Up to 7 years

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

Secondary outcomes

  1. Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals

    Time frame: at 3 month intervals

  2. Biochemical Response at 3 Month Intervals

    Time frame: at 3 month intervals up to 18 moths

  3. Symptom Control at 3 Month Intervals

    Time frame: at 3 month intervals up to 18 moths

  4. Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study

    Time frame: at three-month intervals

  5. Survival

    Time frame: at least on a monthly basis

Sponsors and collaborators

Lead sponsor

Carmen Schade-Brittinger

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2008
Study completion
2013
First posted
Sep 15, 2005
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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