Community-based Neuroendocrine Tumor (NET) Research Study

NCT ID: NCT02730104

Last Updated: 2020-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-23

Study Completion Date

2020-05-13

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroenteropancreatic Neuroendocrine Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A: Patients with small bowel NET

Patients with small bowel NET (including appendiceal NETs)

No interventions assigned to this group

Cohort B: Patients with gastric NET

Patients with gastric NET (gastroduodenal)

No interventions assigned to this group

Cohort C: Patients with pancreatic NET

No interventions assigned to this group

Cohort D: Patients with colorectal NET

Patients with colorectal NET (this includes mid-gut)

No interventions assigned to this group

Cohort E: Unknown primary tumor

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

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Arizona Oncology Associates

Sedona, Arizona, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Site Status

Oncology Hematology Care, Inc.

Cincinnati, Ohio, United States

Site Status

Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center

Beaumont, Texas, United States

Site Status

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas, United States

Site Status

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Site Status

Texas Oncology - Denton South

Denton, Texas, United States

Site Status

Texas Oncology

Houston, Texas, United States

Site Status

Texas Oncology-Tyler

Tyler, Texas, United States

Site Status

Texas Oncology - Deke Slayton Cancer Center

Webster, Texas, United States

Site Status

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36136274 (View on PubMed)

Other Identifiers

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A-US-52030-340

Identifier Type: -

Identifier Source: org_study_id

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