Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
1 other identifier
interventional
85
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2001
Longer than P75 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedResults Posted
Study results publicly available
March 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 26, 2020
March 1, 2020
6.8 years
September 13, 2005
February 28, 2011
March 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Median time to tumor progression at the time of the planned interim analysis that includes all data observed until June 2008.
Up to 7 years
Secondary Outcomes (5)
Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
at 3 month intervals
Biochemical Response at 3 Month Intervals
at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
at 3 month intervals up to 18 moths
Quality of Life (Standardized Questionnaire) at Three-month Intervals in Comparison With the Start of the Study
at three-month intervals
Survival
at least on a monthly basis
Study Arms (2)
Octreotide LAR (Long Acting Release)
EXPERIMENTALOctreotide LAR 30 mg intramuscularly every 28 days
Placebo
PLACEBO COMPARATORPlacebo - Sodium chloride intramuscularly every 28 days
Interventions
30 mg intramuscularly every 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Halle, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Marburg, 35033, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
München, Germany
Related Publications (1)
Rinke A, Muller HH, Schade-Brittinger C, Klose KJ, Barth P, Wied M, Mayer C, Aminossadati B, Pape UF, Blaker M, Harder J, Arnold C, Gress T, Arnold R; PROMID Study Group. 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. J Clin Oncol. 2009 Oct 1;27(28):4656-63. doi: 10.1200/JCO.2009.22.8510. Epub 2009 Aug 24.
PMID: 19704057DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carmen Schade-Brittinger
- Organization
- KKS Marburg
Study Officials
- PRINCIPAL INVESTIGATOR
Rudolf Arnold, MD, Prof
Philipps University Marburg
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-representative
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
September 1, 2001
Primary Completion
June 1, 2008
Study Completion
December 1, 2013
Last Updated
March 26, 2020
Results First Posted
March 28, 2011
Record last verified: 2020-03