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New combo attack: radiation plus surgery for stubborn tumors

NCT ID NCT04609592

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This early-phase study is testing whether giving a radioactive drug called Lutathera both before and after surgery is safe for people with advanced neuroendocrine tumors that have spread to the liver or lymph nodes. The trial will enroll 10 adults whose tumors are considered removable by surgery. The main goal is to see if this combined approach can be done without serious complications, and to gather initial data on tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lutathera (lutetium Lu 177 dotatate)
What this could lead to
If successful, this could show that giving Lutathera before and after surgery is safe and may improve outcomes for people with certain neuroendocrine tumors.
What could go wrong
This is a very early, small phase 1 trial with only 10 participants. It focuses on safety and feasibility, not yet on effectiveness. There are risks from both the radiation and surgery, such as liver or bowel complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Mar 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Metastatic gastroenteropancreatic NET with lymph nodes or liver metastases only. 2. WHO Grade 1 or 2, Ki 67 ≤ 20% (to be confirmed at Stanford) 3. Must be a candidate for cytoreductive surgery with the goal of R1 resection as determined by a multidisciplinary tumor board discussion 4. Measurable disease as determined by RECIST v1.1 5. Confirmed presence of somatostatin receptors on all target lesions as determined by 68Ga DOTA TATE PET scan 6. Patients ≥ 18 years of age. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1 8. Appropriate hematologic, liver and kidney function 9. Patients on octreotide long-acting release (LAR) at a fixed dose of 20 mg or 30 mg at 3 to 4 weeks intervals for at least 12 weeks prior to enrollment in the study Exclusion Criteria: 1. Prior 177Lu Dotatate treatment 2. Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \> 25% of bone marrow, at any time 3. Any chemotherapy or targeted therapy (including everolimus and sunitinib) within 4 weeks prior to enrollment in the study 4. Known brain metastases 5. Known bone or peritoneal metastases

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine neoplasm digestive system neuroendocrine tumor, grade 1/2

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastroenteropancreatic neuroendocrine tumor

Contacts and locations

Locations

  • Stanford Cancer Institute Palo Alto

    Stanford, California, 95304, United States

More trials for these conditions

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