Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized. This trial aims to compare personalized PRRT to non-personalized PRRT in terms of safety, efficacy and resource demands in order to optimize treatment outcomes in an evidence-based manner in future.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lund University Hospital
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• Age ≥18 years

• Written informed consent

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma.

• Somatostatine receptor (SSTR)-expression in tumor lesions > basal liver uptake on 68Ga-DOTA-PET

• Radiologically progressive disease within the last 1-24 months according to common clinical criteria and confirmed by the institutional multidisciplinary conference for the treatment of NETs.

• Measurable disease according to RECIST v 1.1

• Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges peptide receptor radionuclide therapy (PRRT) to be the treatment of choice

• Glomerular filtration rate (GFR) > 50 ml/min/1.73m2 as determined by iohexol- or 51-chromo Crethylendiaminetetraaceticacidtetraacetat) clearance (EDTA) clearance

• Hemoglobin > 90 g/L, platelets >100 x109/L, leukocytes > 3.0x109/L, neutrophils > 1.5 x109/L, aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) < 3 x ULN, bilirubin < 2 x upper limit of normal (ULN), albumin > 25 g/L

• For women of child-bearing potential, highly effective contraception should be used from the time of inclusion up to at least six months after the end of treatment (EOT) visit.

Exclusion Criteria:

• Pregnancy or lactation

• Previous treatment with PRRT

• Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)

• Contraindications for treatment with capecitabine according to the approved label.

• Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTATOC.

• Any other serious, uncontrolled medical or psychiatric condition that, in the opinion of the investigator, precludes the patient from participation in the trial

• Unwillingness, or inability, to participate in any part of the trial procedures or treatments.