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Clinical Trial · NCT05387603
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
Overview
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.
Sponsor
Turku University Hospital
Phase
Phase 3
Contacts
Pernilla Asp, MD, Senior consultant (CONTACT)
pernilla.p.asp@skane.se
+46 46 17 75 20
ClinicalTrials.gov
NCT05387603Eligibility
Inclusion
- GFR \> 50 ml/min/1.73 m2 as determined by iohexol- or 51Cr-EDTA clearance, calculated according to a combination of LMR18 and CAPA formulas, or equally accurate method
- Presence of histologically confirmed, advanced, well-differentiated, inoperable neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for pheochromocytoma and paraganglioma.
- 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
- Eastern Cooperative Oncology Group (ECOG) 0-1
- 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. The CT/MRI that shows tumor progression compared to screening/baseline must have been performed 1-24 months earlier.
- All previous anti-tumor treatment except SSA must be terminated at least 4 weeks before start of treatment within the trial.
- 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.
- Somatostatine receptor (SSTR)-expression in tumor lesions \> basal liver uptake on 68Ga-DOTA-PET
- Measurable disease according to RECIST v 1.1
- 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
Exclusion
- Contraindications for treatment with capecitabine according to the approved label.
- Pregnancy or lactation
- Previous treatment with PRRT
- Unwillingness, or inability, to participate in any part of the trial procedures or treatments.
- 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
- Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)
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