Tailored timing of radioactive therapy may boost tumor control in NETs
NCT ID NCT05387603
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 3 trial tests whether personalizing the schedule of a radioactive drug (177Lu-DOTATOC) improves outcomes for people with advanced neuroendocrine tumors. About 300 participants will receive either a standard or personalized treatment plan, with some also taking capecitabine. The goal is to see if tailoring therapy extends the time before tumors grow again.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-DOTATOC (a radioactive drug) and capecitabine (a chemotherapy pill)
- What this could lead to
- If successful, this could show that personalizing the timing of radioactive therapy improves how long tumors stay controlled, with fewer side effects.
- What could go wrong
- This is a large phase 3 trial, but personalization may not significantly improve outcomes over standard care. Radioactive therapy carries risks like kidney damage and low blood counts.
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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Oct 2026
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: * Age ≥18 years * Written informed consent * Eastern Cooperative Oncology Group (ECOG) 0-1 * Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma. * Somatostatine receptor (SSTR)-expression in tumor lesions \> basal liver uptake on 68Ga-DOTA-PET * Radiologically progressive disease within the last 1-24 months according to common clinical criteria and confirmed by the institutional multidisciplinary conference for the treatment of NETs. The CT/MRI that shows tumor progression compared to screening/baseline must have been performed 1-24 months earlier. * All previous anti-tumor treatment except SSA must be terminated at least 4 weeks before start of treatment within the trial. * Measurable disease according to RECIST v 1.1 * Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges peptide receptor radionuclide therapy (PRRT) to be the treatment of choice * GFR \> 50 ml/min/1.73 m2 as determined by iohexol- or 51Cr-EDTA clearance, calculated according to a combination of LMR18 and CAPA formulas, or equally accurate method * Hemoglobin \> 90 g/L, platelets \>100 x109/L, leukocytes \> 3.0x109/L, neutrophils \> 1.5 x109/L, aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) \< 3 x ULN, bilirubin \< 2 x upper limit of normal (ULN), albumin \> 25 g/L * For women of child-bearing potential, highly effective contraception should be used from the time of inclusion up to at least six months after the end of treatment (EOT) visit. Exclusion Criteria: * Pregnancy or lactation * Previous treatment with PRRT * Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA) * Contraindications for treatment with capecitabine according to the approved label. * Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTATOC. * Any other serious, uncontrolled medical or psychiatric condition that, in the opinion of the investigator, precludes the patient from participation in the trial * Unwillingness, or inability, to participate in any part of the trial procedures or treatments.
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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
4 sites. 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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Accademical Hospital, Uppsala, Dept. of Oncology
RECRUITINGUppsala, SE-752 37, Sweden
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Karolinska University Hospital, Dept. of Oncology
RECRUITINGStockholm, SE-171 76, Sweden
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Sahlgrenska University Hospital, Dept. of Oncology
RECRUITINGGothenburg, Sweden
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Skåne University Hospital, Dept. of Oncology
RECRUITINGLund, SE-226 52, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Swiss registry aims to map rare neuroendocrine tumors
- Can patients drop monthly injections after targeted radiotherapy for neuroendocrine tumors?
- Can a vast image library unlock better pancreatic diagnoses?
- Can a sharper PET tracer light up hidden neuroendocrine tumors?
- Can patient records reveal who will respond to neuroendocrine tumor treatments?
- Can a new drug formulation shrink Hard-to-Treat neuroendocrine tumors?