Gastroenteropancreatic Neuroendocrine TumorsNCT02730104
Community-based Neuroendocrine Tumor (NET) Research Study
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 12 sites in United States.
Trial summary
The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumors
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- 23 Nov 2015to 13 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Community sample
Who may be able to join
- Histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (NET) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. G1 or G2)
- Treatment with lanreotide depot (Somatostatin Analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (LAR) are permitted)
- Radiographically measurable disease
- Has signed the most recent written Patient Informed Consent Form
Who cannot join
- Known hypersensitivity to lanreotide
- Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin
- Patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry
- Significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology - Denton South
Denton, Texas, 76210
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Texas Oncology
Houston, Texas, 75702
Arizona Oncology Associates
Sedona, Arizona, 86336
Texas Oncology-Tyler
Tyler, Texas, 75702
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, 77598
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting
The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Patients with small bowel NET | Patients with small bowel NET (including appendiceal NETs) | |
| Cohort B: Patients with gastric NET | Patients with gastric NET (gastroduodenal) | |
| Cohort C: Patients with pancreatic NET | Not described | |
| Cohort D: Patients with colorectal NET | Patients with colorectal NET (this includes mid-gut) | |
| Cohort E: Unknown primary tumor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
Time to disease progression will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of first documented disease progression or the date of tumor-related death. In a living patient with no documented disease progression, or if the patient is lost to follow-up, disease progression will be censored at the date of the last evaluable scan. Patients who start a new treatment before they progress will be censored as of the date of last scan. Disease progression is defined for this study as both clinical dimensions of progression in conjunction with a treatment change.
Measured: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Secondary outcomes (4)
Overall survival
Overall survival will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of death due to any cause or the last date the patient was known to be alive.
Measured: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Adverse events
Measured: Duration of the study, up to 24 months
Change in flushing and diarrhea
To be assessed as present or not, and if present, as mild, moderate, or severe. At subsequent visits, it should be noted whether these symptoms are better, worse, or the same as at previous visit.
Measured: Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Patient satisfaction with treatment
Treatment Satisfaction Questionnaire for Medication (TQSM-9)
Measured: Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start23 Nov 2015
- Primary completion13 May 2020
- Study completion13 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730104
- Sponsor's protocol ID
- A-US-52030-340
- Status last verified
- Jun 2020
- First submitted
- 1 Apr 2016
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Paulson S, Ray D, Aranha S, Scales A, Wang Y, Liu E. Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study. Oncol Ther. 2022 Dec;10(2):463-479. doi: 10.1007/s40487-022-00208-1. Epub 2022 Sep 22.
PubMed 36136274
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study in Patients With Locally Advanced or Metastatic Gastroenteropancreatic Neuroendocrine Tumors Treated With Lanreotide Depot in a US Community Oncology Setting
- ClinicalTrials.gov ID
- NCT02730104
- Acronym / sponsor ID
- A-US-52030-340
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2015
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 13 May 2020 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with Lanreotide Depot. This is an observational study therefore all data collected will be in accordance with the routine practice of physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Patients with small bowel NET | – | –Patients with small bowel NET (including appendiceal NETs) |
| Cohort B: Patients with gastric NET | – | –Patients with gastric NET (gastroduodenal) |
| Cohort C: Patients with pancreatic NET | – | – |
| Cohort D: Patients with colorectal NET | – | –Patients with colorectal NET (this includes mid-gut) |
| Cohort E: Unknown primary tumor | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- Histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (NET) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. G1 or G2)
- Treatment with lanreotide depot (Somatostatin Analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (LAR) are permitted)
- Radiographically measurable disease
- Has signed the most recent written Patient Informed Consent Form
Key exclusion criteria (4 listed)
- Known hypersensitivity to lanreotide
- Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin
- Patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry
- Significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to disease progression
Time frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Time to disease progression will be defined as the time from the first date of lanreotide, which may have occurred prior to study entry, to the date of first documented disease progression or the date of tumor-related death. In a living patient with no documented disease progression, or if the patient is lost to follow-up, disease progression will be censored at the date of the last evaluable scan. Patients who start a new treatment before they progress will be censored as of the date of last scan. Disease progression is defined for this study as both clinical dimensions of progression in conjunction with a treatment change.
4 secondary outcomes
Overall survival
Time frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised
Adverse events
Time frame: Duration of the study, up to 24 months
Change in flushing and diarrhea
Time frame: Baseline, month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Patient satisfaction with treatment
Time frame: Month 6, 12, 18, 24, end of treatment visit (+/-28 days from patients off treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 36136274Paulson S, Ray D, Aranha S, Scales A, Wang Y, Liu E. Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study. Oncol Ther. 2022 Dec;10(2):463-479. doi: 10.1007/s40487-022-00208-1. Epub 2022 Sep 22.
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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.
Ipsen Medical Director study director
Ipsen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteropancreatic Neuroendocrine Tumors, run by Ipsen at 12 sites in United States.
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 4 inclusion and 4 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 disease progression (time frame: From first date of lanreotide to up to 24 months (approximately) after the last patient is randomised). 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 NCT02730104, 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 Jun 2020.