Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
- Conditions
- Neuroendocrine Tumors
- Registration Number
- NCT05387603
- Lead Sponsor
- Lund University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria:<br><br> - Age =18 years<br><br> - Written informed consent<br><br> - Eastern Cooperative Oncology Group (ECOG) 0-1<br><br> - Presence of histologically confirmed, advanced, well-differentiated, inoperable<br> neuroendocrine tumors (NET) of any primary tumor origin and any grade, except for<br> pheochromocytoma and paraganglioma.<br><br> - Somatostatine receptor (SSTR)-expression in tumor lesions > basal liver uptake on<br> 68Ga-DOTA-PET<br><br> - Radiologically progressive disease within the last 1-24 months according to common<br> clinical criteria and confirmed by the institutional multidisciplinary conference<br> for the treatment of NETs. The CT/MRI that shows tumor progression compared to<br> screening/baseline must have been performed 1-24 months earlier.<br><br> - All previous anti-tumor treatment except SSA must be terminated at least 4 weeks<br> before start of treatment within the trial.<br><br> - Measurable disease according to RECIST v 1.1<br><br> - Given the available, approved anti-tumor treatments and the specific characteristics<br> of the patient and the tumor, the investigator judges peptide receptor radionuclide<br> therapy (PRRT) to be the treatment of choice<br><br> - GFR > 50 ml/min/1.73 m2 as determined by iohexol- or 51Cr-EDTA clearance, calculated<br> according to a combination of LMR18 and CAPA formulas, or equally accurate method<br><br> - Hemoglobin > 90 g/L, platelets >100 x109/L, leukocytes > 3.0x109/L, neutrophils ><br> 1.5 x109/L, aspartate transaminase (ASAT)/alanine aminotransferase (ALAT) < 3 x ULN,<br> bilirubin < 2 x upper limit of normal (ULN), albumin > 25 g/L<br><br> - For women of child-bearing potential, highly effective contraception should be used<br> from the time of inclusion up to at least six months after the end of treatment<br> (EOT) visit.<br><br>Exclusion Criteria:<br><br> - Pregnancy or lactation<br><br> - Previous treatment with PRRT<br><br> - Concomitant systemic anti-tumor therapy other than somatostatin analogue (SSA)<br><br> - Contraindications for treatment with capecitabine according to the approved label.<br><br> - Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor<br> lesions without uptake on 68Ga-DOTATOC.<br><br> - Any other serious, uncontrolled medical or psychiatric condition that, in the<br> opinion of the investigator, precludes the patient from participation in the trial<br><br> - Unwillingness, or inability, to participate in any part of the trial procedures or<br> treatments.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Median progression free survival (PFS) defined as time from randomization to radiological progression.;Median progression free survival (PFS) defined as time from randomization to radiological progression.;Median progression free survival (PFS) defined as time from randomization to radiological progression,
- Secondary Outcome Measures
Name Time Method Rate of treatment-related adverse reactions;Median overall survival (OS).;Progression free survival.;Percent change in sum of longest diameters (SLD) of tumor lesions.;Quality of Life as judged by the patient.;Cumulative median absorbed dose (AD);Correlation between cumulative median absorbed dose and time to progression.;Cumulative median absorbed dose (AD) and biological effective dose to kidneys.;Differences in resource utilization and treatment cost.