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Procedure

Targeted Radiation Therapy Post-Surgery for Metastatic Neuroendocrine Tumors

Q: How might patients be exposed to potential risk with Treatment (surgical debulking, 177Lu dotatate)?

<p>Due to its Phase 4 status, Treatment (surgical debulking, 177Lu dotatate) was allocated a score of 3 on our risk assessment scale due to the approval it has already received.</p>

Q: Are there any available positions in this medical experiment for participants?

<p>This medical study, which was initially published on September 1st 2023 and most recently updated on August 23rd 2023, is not currently enrolling candidates. Nonetheless, there are now 3608 other clinical trials offering individuals an opportunity to participate in a trial.</p>

Phase 4

Recruiting

Led By Kamran Idrees, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Histologically confirmed well-differentiated gastrointestinal or pancreatic neuroendocrine tumor that is grade 1 or grade 2 (Ki-67 =< 20%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial evaluates using a targeted radiation therapy to treat GEP-NETs that have spread to the liver after surgery.

Who is the study for?

This trial is for adults with grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumors that have spread to the liver. Participants must not be pregnant, breastfeeding, and should agree to use contraception. They need a certain level of blood cell counts, kidney function, and no inoperable tumors larger than 3 cm. Those with fully resectable disease or unstable heart conditions are excluded.Check my eligibility

What is being tested?

The study tests if performing surgery to remove as much tumor as possible before giving a radioactive drug called Lutetium Lu 177 dotatate improves treatment outcomes for patients. The drug targets tumor cells through somatostatin receptors and delivers radiation directly to kill them.See study design

What are the potential side effects?

Potential side effects include radiation-related risks such as nausea, fatigue, bone marrow suppression (which can lead to anemia or infection), kidney damage, and possibly allergic reactions related to the infusion of the radioactive substance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of my waking hours.

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My tumor is a low or intermediate grade neuroendocrine tumor in the GI tract or pancreas.

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My kidney function, measured by creatinine clearance, is adequate.

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I am not breastfeeding and agree not to during and for 2.5 months after my lutetium treatment.

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I am 18 years old or older.

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My neuroendocrine tumor shows up on a special scan and is as active as the liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gene mutations

Incidence of adverse events

Overall response rate

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (surgical debulking, 177Lu dotatate)Experimental Treatment6 Interventions

Patients undergo surgical debulking on day 0 and receive 177Lu dotatate IV over 30 to 40 minutes on day 1 of each cycle. Treatment repeats every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI throughout the trial, and undergo dotatate PET/CT during screening and on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,927 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

118 Patients Enrolled for Neuroendocrine Tumors

Kamran Idrees, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might patients be exposed to potential risk with Treatment (surgical debulking, 177Lu dotatate)?

"Due to its Phase 4 status, Treatment (surgical debulking, 177Lu dotatate) was allocated a score of 3 on our risk assessment scale due to the approval it has already received."

Answered by AI

Are there any available positions in this medical experiment for participants?

"This medical study, which was initially published on September 1st 2023 and most recently updated on August 23rd 2023, is not currently enrolling candidates. Nonetheless, there are now 3608 other clinical trials offering individuals an opportunity to participate in a trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors

Kamran Idrees 2024. "Surgical Debulking Prior to Peptide Receptor Radionuclide Therapy in Well Differentiated Gastroenteropancreatic Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016855.

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