Can spacing out radioactive drug doses reduce side effects in neuroendocrine tumors?
NCT ID NCT06878664
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 166 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
21 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre Eugène MARQUIS
NOT_YET_RECRUITINGRennes, Rennes, 35000, France
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Centre François BACLESSE
NOT_YET_RECRUITINGCaen, Caen, 14000, France
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Chu Dijon
NOT_YET_RECRUITINGDijon, Dijon, 21000, France
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Complexo Hospitalario Universitario de Santiago
NOT_YET_RECRUITINGSantiago de Compostela, La Coruña, 15706, Spain
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Hopital BEAUJON
NOT_YET_RECRUITINGClichy, Paris, 92110, France
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Hopital COCHIN
NOT_YET_RECRUITINGParis, Paris, 75014, France
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Hospices civiles de Lyon
NOT_YET_RECRUITINGLyon, Lyon, 69002, France
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Hospital 12 de Octubre
RECRUITINGMadrid, Madrid, 28041, Spain
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Hospital Center University De Lille
NOT_YET_RECRUITINGLille, Lille, 59000, France
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Hospital Clínico de Valencia
RECRUITINGValencia, Valencia, 46010, Spain
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Hospital General Universitario Gregorio Marañón
NOT_YET_RECRUITINGMadrid, Madrid, 28007, Spain
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Hospital Universitari Vall d'Hebrón
RECRUITINGBarcelona, Barcelona, 08035, Spain
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Hospital Universitario Central de Asturias
NOT_YET_RECRUITINGOviedo, Principality of Asturias, 33011, Spain
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Hospital Universitario La Paz
NOT_YET_RECRUITINGMadrid, Madrid, 28046, Spain
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, Madrid, 28034, Spain
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Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITINGSeville, Sevilla, 41013, Spain
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Hospital Universitario de Burgos
RECRUITINGBurgos, Balearic Islands, 09006, Spain
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Hospital Universitario y Politécnico La Fe
RECRUITINGValencia, Valencia, 46026, Spain
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Hospital Virgen de las Nieves de Granada
RECRUITINGGranada, Granada, 18014, Spain
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Institut Paoli Calmette
NOT_YET_RECRUITINGMarseille, Marseille, 13009, France
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Instituto Catalán de Oncología - Hospital Duran i Reynals
RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain