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Second dose of targeted radiation may outperform standard drugs for stubborn gut tumors

NCT ID NCT05773274

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 28 times

Summary

This study tests whether a second round of targeted radiation therapy (177Lu-DOTATATE) works better than standard drugs (everolimus, sunitinib, or cabozantinib) for people with advanced neuroendocrine tumors of the digestive system that have spread and cannot be removed by surgery. About 100 adults whose tumors progressed after initial radiation treatment will be randomly assigned to receive either the radiation retreatment or one of the standard drugs. The main goal is to see which approach delays tumor growth longer.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

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: * Patients must be at least \>= 18 years of age * Metastatic, histologically confirmed grade 1 or 2 well-differentiated gastroenteropancreatic neuroendocrine tumours, including NETs of unknown primary thought to be of gastroenterogancreatic origin, with positive Gallium-68 DOTATATE scan, Copper-64 DOTATATE scan or octreotide scan within the last 12 months is recommended but within the last 36 months is allowed. Lesions on Gallium-68 or Copper-64 DOTATATE scan or octreotide scan will be considered positive if the maximum standardized uptake value (SUVmax) of target lesion is \> SUV mean of normal liver parenchyma * 7th Edition of the TNM Classification of Malignant Tumours * Have received 3 or 4 cycles of PRRT using 177Lu-DOTATATE or a cumulative exposure of 22,200 MBq (600mCi) or 29,600 MBq (800 mCi) within +/- 10% variation within a 52-week period. No previous targeted alpha therapy is permitted * Have had radiological progression per RECIST 1.1 after prior PRRT treatment and no sooner than 12 months from last scan performed post completion of initial PRRT where either stable disease, partial response, or complete response has been maintained throughout. Patients may have received previous systemic anti-cancer therapy subsequently, as long as they had benefited from initial PRRT for at least 12 months and have had confirmed progression per RECIST 1.1 on the intervening systemic anti-cancer therapy. Somatostatin analogues (SSA) administered for functional control are not considered an intervening systemic anti-cancer therapy. If intervening systemic anti-cancer therapy included a vascular endothelial growth factor (VEGF)-inhibitor, sunitinib can not be selected as standard of care on Arm 2. If intervening systemic anti-cancer therapy included an mammalian target of rapamycin (mTOR)-inhibitor, then everolimus can not be selected as the standard of care on Arm 2. If the intervening therapy is an alkylating agent, exposure of alkylating agent cannot exceed 12 months. The 12-month limit will also be applied to pre PRRT alkylator use as well * Patients may have received previous ablative therapy or bland embolization as liver directed therapy however this must not have been received within 12 weeks from randomization date. Previous chemo and radio embolization are not permitted. Any lesion treated with an ablative technique as well as lesions in the lobe(s) of the liver treated with embolization shall not be included in target lesion assessment unless they have since progressed * No ongoing toxicity from prior PRRT that is grade 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Hemoglobin \>= 80 g/L (\>= 8.0 g/dL) (measured within 28 days prior to enrollment) * Absolute neutrophil count \>= 1.0 x 10\^9/L (\>= 1000/mm\^3) (measured within 28 days prior to enrollment) * Platelets \>= 80 x 10\^9/L (\>= 80 x 10\^3/mm\^3) (measured within 28 days prior to enrollment) * Total bilirubin \< 1.5 x upper limit of normal (ULN) (upper limit of normal) (measured within 28 days prior to enrollment) * If confirmed Gilbert's, eligible providing =\< 3.0 x ULN * Creatinine clearance \> 50 mL/min (measured within 28 days prior to enrollment) * Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft and Gault equation * Prior or current use of somatostatin analogues is allowed for carcinoid syndrome control or in PRRT re-treatment patient population (Arm 1). Patients randomized to Arm 2 and receiving everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only) will not be allowed to continue somatostatin analogues unless they have functional syndrome * Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate * Males and females of reproductive potential must have agreed to use a highly effective contraceptive method during protocol treatment and for 7 months after the last dose of protocol treatment for females and 4 months after the last dose of protocol treatment for males. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Men should avoid fathering a child for 4 months after the last dose of 177Lu-DOTATATE * Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of human chorionic gonadotropin (hCG), as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy * Patients must be accessible for treatment, response assessment, and follow up. Patients enrolled on this trial must be treated and followed at the participating center. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up * Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial * Patient must have access to everolimus or sunitinib (pancreatic NET patients only) or cabozantinib (US patients only). In the event that site/investigator is unable to provide access to the drug, patient will not be eligible for this trial * Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial Exclusion Criteria: * Major surgical procedures within 6 weeks from randomization date * Known brain metastases, unless these metastases have been treated, stabilized and off steroids for at least 4 weeks prior to enrollment in the study. Patients with a history of brain metastases must have a head CT and/or MRI with contrast to document stable disease prior to enrollment in the study * Uncontrolled congestive heart failure no worse than New York Heart Association Class (NYHA) IIB * Inability to swallow oral medications or gastrointestinal disease limiting absorption of oral agents * Patients with any other significant medical or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study * Pregnant women are excluded from this study because 177Lu-DOTATATE is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 177Lu-DOTATATE, breastfeeding should be discontinued if the mother is treated with everolimus or sunitinib or cabozantinib (US patients only) and for 2.5 months following the last treatment with 177Lu-DOTATATE

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Conditions

The condition(s) this trial relates to.

digestive system neuroendocrine tumor, grade 1/2

As listed by the trial registrant

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

Metastatic digestive system neuroendocrine tumor G1 Metastatic digestive system neuroendocrine tumor G2 Unresectable digestive system neuroendocrine tumor G1 Unresectable digestive system neuroendocrine tumor G2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    38 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BCCA-Vancouver Cancer Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Banner University Medical Center - Tucson

    RECRUITING

    Tucson, Arizona, 85719, United States

  • CancerCare Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Doctor H. Bliss Murphy Cancer Centre

    RECRUITING

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Henry Ford Hospital

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48202, United States

  • Huntsman Cancer Institute/University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

    Contact Email: •••••@•••••

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • London Regional Cancer Program

    RECRUITING

    London, Ontario, N6A 4L6, Canada

  • Mayo Clinic Hospital in Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Oak Brook

    RECRUITING

    Oak Brook, Illinois, 60523, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Ottawa Hospital and Cancer Center-General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • UC Comprehensive Cancer Center at Silver Cross

    RECRUITING

    New Lenox, Illinois, 60451, United States

    Contact Email: •••••@•••••

  • UCHealth University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    RECRUITING

    Waukee, Iowa, 50263, United States

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    RECRUITING

    Clive, Iowa, 50325, United States

  • UM Sylvester Comprehensive Cancer Center at Aventura

    RECRUITING

    Aventura, Florida, 33180, United States

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • University of Alabama at Birmingham Cancer Center

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Arizona Cancer Center-North Campus

    RECRUITING

    Tucson, Arizona, 85719, United States

  • University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

    Contact Email: •••••@•••••

  • University of Chicago Medicine-Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

    Contact Email: •••••@•••••

  • University of Kentucky/Markey Cancer Center

    ACTIVE_NOT_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    RECRUITING

    North Miami, Florida, 33181, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Rochester

    SUSPENDED

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.