Actively Recruiting
177Lu-DOTATATE for Recurrent Meningioma: a Randomized Phase II Study
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2025-09-16
136
Participants Needed
12
Research Sites
88 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment options for meningiomas that continue to grow despite prior local therapies like surgery and radiotherapy. This study focuses on a precision medicine approach combining diagnostic patient selection with PET molecular imaging and a targeted systemic radioligand therapy called [177Lu]Lu-DOTATATE. This is the first randomized trial investigating this therapy in patients with refractory meningioma, aiming to open new avenues for treatment and research in this area. Participants are randomly assigned to receive either the experimental therapy with intravenous [177Lu]Lu-DOTATATE at a dose of 7.4 GBq every four weeks for four cycles or a control group receiving local standard care as decided by their physician. The control treatments may include hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or no treatment with observation and supportive care. This randomized Phase II study compares the impact of these approaches on meningioma progression. During the study, participants will undergo regular assessments including MRI scans, PET imaging, neurological function evaluations using the NANO scale, and health-related quality of life questionnaires. Researchers will monitor disease progression, survival, radiological response, and treatment side effects up to two years after enrollment. Liver, kidney, blood, and electrolyte function are also checked before treatment. Participants will be followed closely to evaluate the treatment's effect and safety throughout the study period.
CONDITIONS
Brief Title
177Lu-DOTATATE for Recurrent Meningioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years of age or older
- Histologically confirmed diagnosis of meningioma (all WHO CNS5 grades 1-3)
- WHO performance status between 0 and 2
- Measurable meningioma lesion of at least 10 x 10 mm on MRI within two weeks before randomization
- Radiologically documented tumor progression over the last two years or new lesions
- Positive somatostatin receptor expression confirmed by PET scan within four weeks before randomization
- At least one prior surgery and one line of external beam radiotherapy for meningioma
- Adequate liver, kidney, and blood function within four weeks prior to randomization
- Electrolyte levels within normal limits or corrected before first study dose
- Corticosteroid treatment with dexamethasone dose ≤4 mg/day for at least 7 days before treatment start
- Negative pregnancy test for women of childbearing potential prior to randomization
- Use of effective birth control during treatment and for six months after last dose for patients of reproductive potential
- Breastfeeding women must stop nursing before first dose and until seven months after last treatment
- Written informed consent given according to regulations
You will not qualify if you...
- Local therapy (surgery or radiotherapy) is currently indicated
- Any prior or combined systemic treatment for meningioma
- Life expectancy less than nine weeks
- History of invasive cancer within last five years except certain low-risk cancers
- Suspected or unexcluded pregnancy
- Contraindications to MRI, CT, or PET scans
- Unstable heart conditions like recent heart attack, uncontrolled hypertension, or arrhythmias
- Conditions that may prevent compliance with study protocol or follow-up
- Known allergy to the study drug or its ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive either 177Lu-DOTATATE intravenous infusions every four weeks for four cycles or local standard of care treatment as determined by their investigator.
4 visits for infusions every 4 weeks
Duration - Up to 2 years
Participants are monitored for disease progression, survival, neurological function, quality of life, and treatment-related toxicity for up to 2 years after treatment.
Regular follow-up visits during this period
Trial Site Locations
Total: 12 locations
1
A.O Landeskrankenhaus - Innsbruck Universitaetsklinik
Innsbruck, Austria, 6020
Actively Recruiting
2
Universitaetskliniken der Uni Wien - Universitaetsklinikum Wien - AKH unikliniken
Vienna, Austria, 1090
Actively Recruiting
3
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
4
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
5
CHRU de Nancy - Hopitaux De Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
6
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
7
Oslo University Hospital - Radiumhospitalet
Oslo, Norway, 0379
Actively Recruiting
8
St Olavs University Hospital - St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7030
Actively Recruiting
9
Vall D Hebron - Hospital Universitari Vall d'Hebron -Vall d'Hebron Institut Oncologia
Barcelona, Spain, 08035
Actively Recruiting
10
Hospital Universitario 12 De Octubre
Madrid, Spain, 28041
Actively Recruiting
11
Oncology Institute of Southern Switzerland (IOSI) - Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Not Yet Recruiting
12
UniversitaetsSpital Zurich - Neurology Clinic
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
E
EORTC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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