Neuroendocrine TumorsPhase 3NCT00171873

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

A Phase 3 study testing Octreotide LAR (Long-acting release) in people with Neuroendocrine Tumors, run by Carmen Schade-Brittinger at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuroendocrine Tumors
What is being tested?: Octreotide LAR (Long-acting release)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 85 participants
Where: 10 sitesGermany
Study dates: Sep 2001to Dec 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Germany10 sites

Novartis Investigative Site
Bochum
Novartis Investigative Site
Dresden
Novartis Investigative Site
Halle
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Kiel
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Mainz
Novartis Investigative Site
Marburg, 35033
Novartis Investigative Site
Marburg
Novartis Investigative Site
München

Other trials in Germany

About this study

Official title: Study to Investigate the 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

Conditions: Neuroendocrine Tumors
Being tested: Octreotide LAR (Long-acting release), Placebo
Keywords: Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor, Midgut
Medical subject headings: Neuroendocrine Tumors, Disease, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Octreotide LAR (Long-acting release)Drug
Also called SMS995
30 mg intramuscularly every 28 days
PlaceboDrug
Sodium chloride intramuscularly every 28 days

Study groups in NCT00171873
Study group	Role	What they receive
Octreotide LAR (Long Acting Release)	Experimental	Octreotide LAR 30 mg intramuscularly every 28 days Receives: Drug: Octreotide LAR (Long-acting release)
Placebo	Placebo comparator	Placebo - Sodium chloride intramuscularly every 28 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 7 years

Secondary outcomes (5)

Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Measured: at 3 month intervals
Biochemical Response at 3 Month Intervals
Measured: at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
Measured: 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
Measured: at three-month intervals
Survival
Measured: at least on a monthly basis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2001Dec 2013

First posted15 Sep 2005 (estimated)
Study startSep 2001
Primary completionJun 2008
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00171873
Sponsor's protocol ID: CSMS995ADE05
Status last verified: Mar 2020
First submitted: 13 Sep 2005
Last updated: 26 Mar 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 19704057

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitationObservational study
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Prostate Cancer, Leukemia
RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
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All Neuroendocrine Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Investigate the Antiproliferative Effect of Octreotide in Patients With Metastasized Neuroendocrine Tumors of the Midgut
ClinicalTrials.gov ID: NCT00171873
Acronym / sponsor ID: CSMS995ADE05
Conditions: Neuroendocrine Tumors
Keywords: Double blind, Phase III, Disease, Clinical trial, Octreotide, Neuroendocrine tumor, Cancer, Tumor
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Carmen Schade-BrittingerUniversity, hospital or other
Study start: Sep 2001
Primary completion: Jun 2008 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Sep 2005 (estimated)
Results: Posted 28 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Octreotide LAR (Long Acting Release)	Experimental	Drug: Octreotide LAR (Long-acting release)Octreotide LAR 30 mg intramuscularly every 28 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo - Sodium chloride intramuscularly every 28 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Octreotide LAR (Long-acting release)Also: SMS99530 mg intramuscularly every 28 days	Drug	Octreotide LAR (Long Acting Release)
PlaceboSodium chloride intramuscularly every 28 days	Drug	Placebo

Primary outcome

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.

5 secondary outcomes

Objective Response Rates According to World Health Organization (WHO) Criteria at 3 Month Intervals
Time frame: at 3 month intervals
Biochemical Response at 3 Month Intervals
Time frame: at 3 month intervals up to 18 moths
Symptom Control at 3 Month Intervals
Time frame: 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
Time frame: at three-month intervals
Survival
Time frame: at least on a monthly basis

Results and safety

Results posted to the registry on 28 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Octreotide LAR (SMS995)	42	33
Placebo	43	40

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

Time frame: Up to 7 years. Median (95% Confidence Interval). Unit: Months

Measure	Octreotide LAR (SMS995) n = 39	Placebo n = 42
Value	14.3 (11.0 to 28.8)	6.0 (3.7 to 9.4)

Population analysed: Conservative Intent to Treat (ITT) population consisting of all participants who received study drug. 3 participants in the Octreotide group and 1 participant in the placebo group without liver involvement at the beginning of the study were excluded from this analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Octreotide LAR (SMS995)	11 of 42 (26.2%)	19 of 42 (45.2%)	Not reported
Placebo	10 of 43 (23.3%)	11 of 43 (25.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19704057Rinke 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.

Related trials for Neuroendocrine Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
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Enrolling by invitationObservational study
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RecruitingPhase 3
Somatostatin Analogues vs. Observation After Peptide Receptor Radionuclide Therapy (PRRT) in Nonfunctional Neuroendocrine Neoplasms
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rudolf Arnold, MD, Prof principal investigator

Philipps University Marburg

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octreotide LAR (Long-acting release) in people with Neuroendocrine Tumors, run by Carmen Schade-Brittinger at 10 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Tumor Progression Documented by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) (time frame: Up to 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00171873, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.