Efficacy and safety of adjuvant peptide receptor radionuclide therapy after curative surgery of locoregional limited small intestine neuroendocrine neoplasia – a multi-center, prospective, open-label, two-arm parallel group, randomized, controlled, phase III study
interventional
N/A
1 country
8
Primary objective is to evaluate the efficacy of adjuvant treatment with PRRT in Arm A (experimental) compared to standard care based on close surveillance in Arm B (control) in terms of relapse-free survival (RFS) at 60 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2025
Actual (reported)RFS will be defined as the time from randomization to first relapse or death, whichever occurs earlier (acc. to ENETS guidelines). Relapse is defined as newly detected lesion with SSTR uptake in PET-CT.
Overall Survival (OS) and cancer-specific OS will be defined as the time from randomization to death/ cancer-specific death.
AEs/SAEs
HRQOL will be measured by means of EORTC QLQ-C30/ GINET21 questionnaires.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Lutathera 370 MBq/mL solution for infusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Lutathera 370 MBq/mL solution for infusion
Named ingredient: lutetium (177Lu) oxodotreotide
View registry recordUniversitaetsklinikum Koeln AöR
Cologne, 50937, Germany
Universitaetsklinikum Magdeburg AöR
Magdeburg, 39120, Germany
Universitaetsklinikum Essen AöR
Essen, 45147, Germany
Dr. Hasan Avci
First Submitted
May 16, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
A Clinical Trial Evaluating the Safety of Combining Lutathera(R) and Azedra(R) to Treat Mid-gut Neuroendocrine Tumors
Contact the study team to confirm eligibility.
Philipps-Universitaet Marburg
Marburg, 35043, Germany
Universitaetsklinikum Wuerzburg AöR
Wuerzburg, 97080, Germany
Universitaetsklinikum Tuebingen AöR
Tuebingen, 72076, Germany
Universitaetsklinikum Bonn AöR
Bonn, 53127, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, 81675, Germany