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Adjuvant radioligand therapy in neuroendocrine tumors
EU CTIS ID: 2024-518236-36-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent
- Age ≥ 18
- Preoperative positive functional Somatostatin receptor (SRS) imaging by PET-CT
- 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
- Tumor grading G1, G2 or G3 (WHO classification)
- Postoperative negative functional Somatostatin receptor (SRS) imaging by PET-CT
You likely can't join if
- Patients unfit for study therapy (ECOG performance status of 4)
- Pregnancy
- Breast-feeding
- Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
- Prohibited Medication: • Long-acting analogs of somatostatin within 4 weeks before first administration of Lutathera® • Short-acting somatostatin analogs within 24 hours before administration of Lutathera® • Repeated administration of high-doses of glucocorticosteroids
See the full eligibility criteria
Who can join
- Written informed consent
- Age ≥ 18
- Preoperative positive functional Somatostatin receptor (SRS) imaging by PET-CT
- 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
- Tumor grading G1, G2 or G3 (WHO classification)
- Postoperative negative functional Somatostatin receptor (SRS) imaging by PET-CT
- 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.
- 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: • Information of the partner of their participation in the study and the need to comply with contraception instructions as directed by the investigator. • Male participants are required to use a condom during treatment and until at least 4 months after the last administration of study medication. • Female 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. • Sperm 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: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • Bilateral tubal occlusion • Vasectomized partner • Sexual abstinence
What rules you out
- Patients unfit for study therapy (ECOG performance status of 4)
- Pregnancy
- Breast-feeding
- Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study
- Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
- Prohibited Medication: • Long-acting analogs of somatostatin within 4 weeks before first administration of Lutathera® • Short-acting somatostatin analogs within 24 hours before administration of Lutathera® • Repeated administration of high-doses of glucocorticosteroids
- Concurrent participation in another interventional pharmaceutical trial
- Distant Metastases
- Creatinine clearance < 40 mL/min calculated by the Cockroft Gault method
- Hb concentration < 5.0 mmol/L (< 8.0 g/dL)
- WBC < 2 x 10^9/L (2000 / mm^3)
- Platelets < 75 x 10^9/L (75 x 10^3 / mm^3)
- Total bilirubin > 3 x upper limit of normal
- Serum albumin < 3.0 g/dL unless prothrombin rate is within the normal range
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.