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Procedure

Targeted Radiation Therapy Post-Surgery for Metastatic Neuroendocrine Tumors

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%)

Must not have

Patient has grade 3 neuroendocrine neoplasm (well-differentiated or poorly-differentiated tumor)

Prior receipt of peptide receptor radionuclide therapy (PRRT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor is a grade 3 neuroendocrine type.

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I have previously received PRRT treatment.

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I do not have severe heart problems like unstable angina or serious heart failure.

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I have a tumor larger than 3 cm that cannot be removed with surgery.

Select...

My disease can be fully removed with surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gene mutations

Incidence of adverse events

Overall response rate

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200