Lutetium (177Lu) oxodotreotide for Small intestine neuroendocrine tumour | Stage III (locoregionally restricted) small intestine neuroendocrine tumour

Inclusion criteria

• {"criterion_text":"- Written informed consent"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- Preoperative positive functional Somatostatin receptor (SRS) imaging by PET-CT"}
• {"criterion_text":"- Histologically confirmed resected locoregionally limited SI-NEN (UICC stage III), which may be achieved by one or more surgical interventions: a. Palpation of the entire small bowel, b. At least 8 lymph nodes are removed, c. R0 situation according to pathology"}
• {"criterion_text":"- Tumor grading G1, G2 or G3 (WHO classification)"}
• {"criterion_text":"- Postoperative negative functional Somatostatin receptor (SRS) imaging by PET-CT"}
• {"criterion_text":"- For women of childbearing potential (a woman is considered of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy): Agreement to practice a highly effective method of contraception (as defined in 8.) from the date of consent until at least 7 months after last study treatment."}
• {"criterion_text":"- Non-sterilized male participants who are sexually active with a female partner of child-bearing potential are eligible to participate in the study if they agree to the following during treatment and until at least 4 months after the last administration of study medication: •\tInformation of the partner of their participation in the study and the need to comply with contraception instructions as directed by the investigator. •\tMale participants are required to use a condom during treatment and until at least 4 months after the last administration of study medication. •\tFemale partners have to agree to practice a highly effective method of contraception (as defined below) from the date of consent until at least 4 months after last study treatment. •\tSperm donation is not allowed during treatment and until at least 4 months after the last administration of study medication. Highly effective methods of contraception according to CTFG guidance include: •\tCombined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal •\tProgestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable •\tIntrauterine device (IUD) •\tIntrauterine hormone-releasing system (IUS) •\tBilateral tubal occlusion •\tVasectomized partner •\tSexual abstinence"}

Exclusion criteria

• {"criterion_text":"- Patients unfit for study therapy (ECOG performance status of 4)"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Breast-feeding"}
• {"criterion_text":"- Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study"}
• {"criterion_text":"- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study"}
• {"criterion_text":"- Prohibited Medication: •\tLong-acting analogs of somatostatin within 4 weeks before first administration of Lutathera® •\tShort-acting somatostatin analogs within 24 hours before administration of Lutathera® • Repeated administration of high-doses of glucocorticosteroids"}
• {"criterion_text":"- Concurrent participation in another interventional pharmaceutical trial"}
• {"criterion_text":"- Distant Metastases"}
• {"criterion_text":"- Creatinine clearance < 40 mL/min calculated by the Cockroft Gault method"}
• {"criterion_text":"- Hb concentration < 5.0 mmol/L (< 8.0 g/dL)"}
• {"criterion_text":"- WBC < 2 x 10^9/L (2000 / mm^3)"}
• {"criterion_text":"- Platelets < 75 x 10^9/L (75 x 10^3 / mm^3)"}
• {"criterion_text":"- Total bilirubin > 3 x upper limit of normal"}
• {"criterion_text":"- Serum albumin < 3.0 g/dL unless prothrombin rate is within the normal range"}
• {"criterion_text":"- Contraindication for Lutathera® (e.g., hypersensitivity to the active substance or to any of the following excipients: acetic acid, sodium acetate, gentisic acid, ascorbic acid, pentetic acid, sodium chloride or sodium hydroxide)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"RFS defined as time from randomization to first relapse or death (per ENETS guidelines). Relapse defined as newly detected lesion with somatostatin receptor (SSTR) uptake on PET-CT."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS) and cancer-specific OS will be defined as the time from randomization to death/ cancer-specific death.","definition_or_measurement_approach":"OS and cancer-specific OS defined as time from randomization to death/cancer-specific death."}
• {"endpoint_text":"- AEs/SAEs","definition_or_measurement_approach":"Adverse events and serious adverse events as reported and graded per study safety reporting procedures (no further definition provided)."}
• {"endpoint_text":"- HRQOL will be measured by means of EORTC QLQ-C30/ GINET21 questionnaires.","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ-C30 and GINET21 questionnaires."}

Germany

Earliest CTIS Part Ii Submission Date

04-07-2025

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

285

Number Of Sites

5

Number Of Participants

160

Primary sponsor

Full Name

Philipps-Universitaet Marburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Deutsche Krebshilfe (DKH): Bearbeitungsnummer 70115125","duties_or_roles":"Monetary support / funding","organisation_type":""}
• {"country":"","full_name":"Advanced Accelerator Applications International S. A. (ADACAP)","duties_or_roles":"Monetary support / funding","organisation_type":""}