Can spacing out radioactive drug doses reduce side effects in neuroendocrine tumors?

NCT ID NCT06878664

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two schedules of the radioactive drug Lu177-Dotatate in 166 people with slow-growing midgut neuroendocrine tumors. One group gets the drug every 8 weeks (standard), the other every 16 weeks. The goal is to see if the less frequent schedule causes fewer blood-related side effects while still controlling the tumor. Participants must have tumors that express somatostatin receptors and have shown slow progression.

What this could mean

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

Active substance
Lu177-Dotatate (a radioactive drug that targets tumor cells)
What this could lead to
If successful, this could show that a less frequent dosing schedule of Lu177-Dotatate is safer and just as effective for controlling slow-growing midgut neuroendocrine tumors.
What could go wrong
This is a Phase 2/3 trial with 166 patients, so results are not yet proven. The less frequent schedule might be less effective at controlling the tumor, and side effects like blood toxicity or secondary cancers remain possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 166 people

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

Started

Jun 2025

Expected to finish

Jan 2029

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. Patients who have histologically confirmed diagnosis of unresectable, advanced or metastatic midgut NETs (originated in the jejunum-ileum or right colon) who are candidates to receive 177Lu-Dotatate targeted radioligand therapy (RLT) and SSA. Patients with a large SRI+ mesenteric mass with abdominal-dominant disease judged by the investigator to be a midgut NET will also be eligible. 2. Ki-67 index ≤ 20%. 3. Disease progression per RECIST v1.1 within 36 months prior to study entry, 4. Patients may be treatment naïve (first-line) or have received prior systemic therapy except for any type of prior RLT (not restricted to 177Lu-Dotatate). 5. In somatostatin receptor (SSTR) imaging all RECIST v1.1 evaluable target lesions and non-target lesions need to be SSTR positive (SSTR+) as defined by equal or above the liver uptake (this includes lesions of at least 10 mm in diameter in CT or MRI). If an FDG PET is performed (not mandatory), all FDG PET positive lesions should also be somatostatin receptor positive in SSRT imaging (see guidance Appendix 10). 6. Measurable disease according to RECIST v1.1 criteria (Appendix 3) 7. Adequate organ function (hematological, renal and liver) based upon meeting all of the following laboratory criteria: * Neutrophil count (ANC) ≥ 2.000/mm3 * Platelet count ≥ 75 × 109/L * Hemoglobin ≥ 8 g/dL * Serum bilirubin ≤ 3.0 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease * Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. * Creatinine clearance (CrCl) ≥ 50 mL/min as estimated by the Cockroft-Gault formula or as measured by 24-hour urine collection (GFR can also be used instead of CrCl). Note: renal tract obstruction is not allowed. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for subjects with liver metastases 8. Karnofsky performance status (KPS) scale ≥ 70% 9. Patient information and signing of the consent form, Institutional Review Board(IRB)/Independent Ethics Committee (IEC) approved, before any study-specific procedure. The patient must be able and willing to cooperate in monitoring study visits and procedures. 10. Patients ≥ 18 years of age. 11. Recovery to Grade ≤ 1 from any adverse event (AE) from prior treatment (excluding alopecia and/or asthenia). 12. Life expectancy ≥ 12 months. 13. Patients with health coverage (public or private), that includes coverage for patients enrolled in clinical trials, to both study treatments and determinations/procedures. 14. Female subject must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 4) for the duration of the study treatment and for 7 months after the final dose of study treatment. Sexually active men must agree to use the male condom during the study and until at least 7 months after the last administration of treatment. Additionally, it is recommended that your female partner of childbearing age use a highly effective method of contraception. 15. Subject agrees not to participate in another interventional study while on treatment in the present study. Exclusion Criteria: 1. Patients who have known hypersensitivity to lutetium-177 (177Lu), oxodotreotide, DOTA, somatostatin analogues, lysine, arginine, or any excipient/derivative of these agents 2. Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow 3. Prior whole liver internal radiation therapy (SIRT) 4. Prior radioligand therapy (RLT) (not restricted to 177Lu-Dotatate). 5. Prior major surgery, systemic therapy, embolization or other locoregional treatments within 4 weeks of study entry 6. Patients who have a known active Hepatitis B (e.g., HBsAg reactive) or active hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients who have a known active history of human immunodeficiency virus (HIV) infection (HIV 1 or 2). 7. Other known malignancies unless cured or definitively treated with no evidence of recurrence for 3 years 8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune, cardiovascular or dementia), that may interfere with the objectives of the trial or with the safety or compliance of the patient, as judged by the investigator. 9. Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 7 months after the final study drug administration. 10. Male patients must agree not to donate sperm starting at screening and throughout the study period, and for at least 4 months after the final study drug administration. 11. Pregnancy or lactation. Men and women should not procreate during study treatment and until seven months after the final study drug administration. 12. For female patients of childbearing potential (defined as \< 2 years after last menstruation and not surgically sterile) and male patients who are not surgically sterile and have female partners of childbearing potential that do not agree to use a medically accepted and highly effective birth control method (i.e. those with a failure rate less than 1%; refer to Appendix 4) for the duration of the study treatment and for 7 months after the final dose of study treatment 13. Patient under guardianship or curatorship or deprived of liberty by a judicial or administrative decision or patient unable to give consent.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • Centre Eugène MARQUIS

    NOT_YET_RECRUITING

    Rennes, Rennes, 35000, France

  • Centre François BACLESSE

    NOT_YET_RECRUITING

    Caen, Caen, 14000, France

  • Chu Dijon

    NOT_YET_RECRUITING

    Dijon, Dijon, 21000, France

  • Complexo Hospitalario Universitario de Santiago

    NOT_YET_RECRUITING

    Santiago de Compostela, La Coruña, 15706, Spain

  • Hopital BEAUJON

    NOT_YET_RECRUITING

    Clichy, Paris, 92110, France

  • Hopital COCHIN

    NOT_YET_RECRUITING

    Paris, Paris, 75014, France

  • Hospices civiles de Lyon

    NOT_YET_RECRUITING

    Lyon, Lyon, 69002, France

  • Hospital 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Center University De Lille

    NOT_YET_RECRUITING

    Lille, Lille, 59000, France

  • Hospital Clínico de Valencia

    RECRUITING

    Valencia, Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañón

    NOT_YET_RECRUITING

    Madrid, Madrid, 28007, Spain

  • Hospital Universitari Vall d'Hebrón

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias

    NOT_YET_RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocío

    NOT_YET_RECRUITING

    Seville, Sevilla, 41013, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, Balearic Islands, 09006, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, Valencia, 46026, Spain

  • Hospital Virgen de las Nieves de Granada

    RECRUITING

    Granada, Granada, 18014, Spain

  • Institut Paoli Calmette

    NOT_YET_RECRUITING

    Marseille, Marseille, 13009, France

  • Instituto Catalán de Oncología - Hospital Duran i Reynals

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain