Status:
RECRUITING
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
Lead Sponsor:
Lund University Hospital
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ai...
Eligibility Criteria
Inclusion
- 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. 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.
- 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
- 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
- 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
- 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.
Key Trial Info
Start Date :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05387603
Start Date
November 1 2022
End Date
October 1 2026
Last Update
September 10 2025
Active Locations (4)
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1
Sahlgrenska University Hospital, Dept. of Oncology
Gothenburg, Sweden
2
Skåne University Hospital, Dept. of Oncology
Lund, Sweden, SE-226 52
3
Karolinska University Hospital, Dept. of Oncology
Stockholm, Sweden, SE-171 76
4
Accademical Hospital, Uppsala, Dept. of Oncology
Uppsala, Sweden, SE-752 37