Adjuvant radioligand therapy in neuroendocrine tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Philipps-Universitaet Marburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Hormonal diseases [C19]

Trial duration

12 Mar 2026 → ongoing

Decision date (initial)

2025-07-14

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Deutsche Krebshilfe (DKH): Bearbeitungsnummer 70115125 · Advanced Accelerator Applications International S. A. (ADACAP)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

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.

Secondary objectives 3

1. To evaluate the efficacy of Arm A (experimental) compared to Arm B (control) in terms of overall survival (OS) and cancer-specific overall survival (OS).
2. To evaluate the safety and tolerability of Arm A (experimental) compared to Arm B (control).
3. To evaluate health-related quality of life (HRQOL) associated with Arm A (experimental) compared to Arm B (control).

Conditions and MedDRA coding

Locoregionally restricted (stage III) small intestinal neuroendocrine neoplasms (SI-NEN)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Written informed consent
2. Age ≥ 18
3. Preoperative positive functional Somatostatin receptor (SRS) imaging by PET-CT
4. 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
5. Tumor grading G1, G2 or G3 (WHO classification)
6. Postoperative negative functional Somatostatin receptor (SRS) imaging by PET-CT
7. 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.
8. 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

Exclusion criteria 15

1. Patients unfit for study therapy (ECOG performance status of 4)
2. Distant Metastases
3. Creatinine clearance < 40 mL/min calculated by the Cockroft Gault method
4. Hb concentration < 5.0 mmol/L (< 8.0 g/dL)
5. WBC < 2 x 10^9/L (2000 / mm^3)
6. Platelets < 75 x 10^9/L (75 x 10^3 / mm^3)
7. Total bilirubin > 3 x upper limit of normal
8. Serum albumin < 3.0 g/dL unless prothrombin rate is within the normal range
9. 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).
10. Pregnancy
11. Breast-feeding
12. Peptide receptor radionuclide therapy (PRRT) at any time prior to randomization in the study
13. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
14. 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
15. Concurrent participation in another interventional pharmaceutical trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 3

1. Overall Survival (OS) and cancer-specific OS will be defined as the time from randomization to death/ cancer-specific death.
2. AEs/SAEs
3. HRQOL will be measured by means of EORTC QLQ-C30/ GINET21 questionnaires.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Philipps-Universitaet Marburg

Sponsor organisation

Philipps-Universitaet Marburg

Address

Karl-Von-Frisch-Strasse 4

City

Marburg

Postcode

35043

Country

Germany

Scientific contact point

Organisation

Philipps-Universitaet Marburg

Contact name

Dr. Hasan Avci

Public contact point

Organisation

Philipps-Universitaet Marburg

Contact name

Dr. Hasan Avci

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications