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New treatment option for Neuroendocrine Tumors
Official title Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors.
ClinicalTrials.gov ID: NCT05387603
What this study is testing
What is 177Lu-DOTATOC?
177Lu-DOTATOC is an investigational medicine, being studied as a potential treatment for neuroendocrine tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There are several ways of personalizing PRRT (peptide receptor radionuclide treatment) in NEN (neuroendocrine neoplasia). Nevertheless, the current treatment regimen is not personalized.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Somatostatine receptor (SSTR)-expression in tumor lesions \> basal liver uptake on 68Ga-DOTA-PET
You likely can't join if
- 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...
See the full eligibility 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...
- 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) \ 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Lund, Sweden; Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.