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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00171873 (opens ClinicalTrials.gov in a new tab)Other idCSMS995ADE05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
85 participants (actual)
Sponsor
Carmen Schade-Brittinger · Other
Design
Randomized · Quadruple masking
Countries
1 country

Germany

Start
Sept 2001
Primary completion
Jun 2008
Completion
Dec 2013
First posted
15 Sept 2005 (estimated)
Last update posted
26 Mar 2020
Conditions
Neuroendocrine Tumors

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20052010
  1. Ph 3

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

    NCT00171873

    Sept 2001 to Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Octreotide LAR (Long-acting release)Drug
  • PlaceboDrug

Arms2

  • Experimental

    Octreotide LAR (Long Acting Release)

    Octreotide LAR 30 mg intramuscularly every 28 days

  • Placebo comparator

    Placebo

    Placebo - Sodium chloride intramuscularly every 28 days

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Up to 7 years

    Registry description

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

Secondary outcomes(5)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 7 years

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

GroupValue (Months)
Octreotide LAR (SMS995)14.3
Placebo6.0
Secondary and other outcome results(5)
Secondary outcome· at 3 month intervals

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

GroupValue
Secondary outcome· at 3 month intervals up to 18 moths

Biochemical Response at 3 Month Intervals

GroupValue
Secondary outcome· at 3 month intervals up to 18 moths

Symptom Control at 3 Month Intervals

GroupValue
Secondary outcome· at three-month intervals

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

GroupValue
Secondary outcome· at least on a monthly basis

Survival

GroupValue

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotide LAR (SMS995)Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days–11 / 4219 / 42
PlaceboSodium chloride intramuscularly every 28 days–10 / 4311 / 43

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2009

6 results

Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.

Rinke et al. 2009Journal of clinical oncology : official journal of the American Society of Clinical Oncologycited by 1,700

PMID 19704057DOI 10.1200/jco.2009.22.8510PUB-19704057

Full text at the publisher6 results
Publisher pageSee results (6)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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