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Clinical Trials in Sweden / NCT05387603
Recruiting Phase 3

Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.

NCT05387603 · tracked via the Priya Life Science Sweden tracker
Sponsor
Lund University Hospital
Phase
Phase 3
Started
2022-11-01
Last updated
2025-09-10

Condition(s) studied

Neuroendocrine Tumors

Investigational drug(s) / intervention(s)

177Lu-DOTATOC →Capecitabine →

177Lu-DOTATOC: The investigational medicinal product (IMP) is 177Lu-DOTATOC which is registered as an orphan drug by the EMA ( European Medicines Agency) for the treatment of GEP-NEN (gastro-entero-pancreatic neuroendocrine tumor). The IMP will be administered to participants both in the control arm and the experimental arms, but with different intervals, but the same activity; 7.5 Gbq per dosing.

Capecitabine: Will be given orally with a dose of 825/m2 twice daily, starting on day 1 of each of the 4 first treatment cycles, cycle length 3 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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. 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 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.

Primary outcome measure(s)

  • Median progression free survival (PFS) defined as time from randomization to radiological progression. — Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks weeks, at follow up (every 3-6 month (investigators choice) until progression.
    Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.
  • Median progression free survival (PFS) defined as time from randomization to radiological progression. — Before start of treatment (within 4 weeks), then every 10 +/- week at follow up (every 3-6 month (investigators choice) until death.
    Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 10 +/- 2 weeks.
  • Median progression free survival (PFS) defined as time from randomization to radiological progression, — Before start of treatment (within 4 weeks), then every 10 +/- 2 weeks, at follow up (every 3-6 month (investigators choice) or patients withdrawal of concent.. No end can be given.
    Time to progression is evaluated by CT (computed tomography) or MRI (magnetic resonance imaging) after every 16-22 weeks.

Trial sites (4)

FacilityCityRegionStatus
Sahlgrenska University Hospital, Dept. of Oncology Gothenburg Sweden Recruiting
Skåne University Hospital, Dept. of Oncology Lund Sweden Recruiting
Karolinska University Hospital, Dept. of Oncology Stockholm Sweden Recruiting
Accademical Hospital, Uppsala, Dept. of Oncology Uppsala Sweden Recruiting

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Standardized Osteotomy Guides for Free Flap Reconstruction of Continuous Defects of the Jaws - a Simplified Method Enrolling by invitation
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients Recruiting
Virtual Planning of Total Temporomandibular Joint Replacement Recruiting

Other trials for the same condition

Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05387603 on ClinicalTrials.gov ↗ ← All trials in Sweden