WithdrawnPhase 2

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl

Stopped: Funder decision

United States0Started 2021-03-03

Plain-language summary

The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Males and females, aged 18 and older * Histologically-confirmed neuroendocrine tumor (GI or other primary) * Presence of somatostatin receptors as by either Ga-68 dotatate imaging or Octreoscan or comparable method, which is a requirement for PRRT (Lutathera ®). Disease does not need to be measurable per RECIST since it is not uncommon to have non-target lesions but not meet criteria for RECIST as long as presence of somatostatin receptors can be demonstrated. NOTE: Patients undergoing other types of PRRT would not be eligible for this clinical trial. * Eligible for treatment with PRRT (Lutathera®) according to institutional practice and product label. * Patient with current or prior history of symptomatic carcinoid syndrome or carcinoid diarrhea as per investigator assessment. Note: prior history and current controlled carcinoid patients are eligible. * Demonstrate adequate organ function as defined in the protocol; all screening labs to be obtained within 28 days prior to registration. * Life expectancy greater than 12 weeks as per investigator opinion * ECOG performance status 0-2 * Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum βhCG) within 7 days prior to study registration. If a urine test is positive or cannot be confirm…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FACT-QS global QoL Score

Timeframe: From enrollment until completion of study therapy or subject withdrawal, up to six months

Trial details

NCT IDNCT04713202

SponsorChandrikha Chandrasekhara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02

View on ClinicalTrials.gov More Neuroendocrine Tumors trials