Personalized treatment for neuroendocrine tumors using targeted radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.