Personalized treatment for neuroendocrine tumors using targeted radiation therapy
Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An Open-label, Multicenter, Randomized Phase III Trial Comparing Safety and Efficacy of Personalized Versus Non-personalized Radionuclide Therapy With 177Lu (Lutetium)-DOTATOC.
PHASE3 · Lund University Hospital · NCT05387603
This study is testing whether a personalized type of radiation therapy can work better than a standard version for people with advanced neuroendocrine tumors.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lund University Hospital (other) |
| Locations | 4 sites (Gothenburg and 3 other locations) |
| Trial ID | NCT05387603 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare personalized peptide receptor radionuclide therapy (PRRT) with non-personalized PRRT for patients with advanced neuroendocrine tumors. The study will evaluate the safety, efficacy, and resource demands of these two approaches to optimize treatment outcomes. Participants will receive 177Lu-DOTATOC and Capecitabine as part of their treatment regimen. The goal is to establish a more effective and tailored treatment strategy for patients with neuroendocrine tumors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced, well-differentiated, inoperable neuroendocrine tumors that have shown radiological progression.
Not a fit: Patients with pheochromocytoma or paraganglioma, or those who have not shown tumor progression within the specified timeframe, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with neuroendocrine tumors.
How similar studies have performed: Other studies have shown promise in personalized radionuclide therapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Gothenburg and 3 other locations
- 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)
Study contacts
- Study coordinator: Pernilla Asp, MD, Senior consultant
- Email: pernilla.p.asp@skane.se
- Phone: +46 46 17 75 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuroendocrine Tumors, Neuroendocrine tumors, Radionuclide therapy, Personalized radionuclide therapy, 177Lu-DOTATOC, Capecitabine, Dosimetry-based radionuclide therapy, Somatostatin receptor