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Systemic Targeted Adaptive RadioTherapy of NeuroEndocrine Tumors. An open-label, multi-center, randomized phase III trial comparing safety and efficacy of personalized vs non-personalized radionuclide therapy with 177Lu-DOTATOC
EU CTIS ID: 2023-508572-11-00
What this study is testing
The primary objective of this study is to compare the efficacy of personalized vs nonpersonalized PRRT with 177Lu-DOTATOC in patients with SSTR-positive NET G1-G3.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject has given written informed consent to participate in the study.
- Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges 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
- Adequate hematological parameters as defined by: Hemoglobin > 90 g/L, platelets >100 x109/L, leukocytes > 3.0x109/L, neutrophils > 1.5 x109/L
- Adequate hepatic function as defined by ASAT/ALAT < 3 x ULN, bilirubin < 2 x ULN, albumin > 25 g/L.
- For women of child-bearing potential, highly effective contraception should be usedfrom the time of inclusion up to at least six months after the EOT visit. For details see appendix 5.
You likely can't join if
- Pregnancy or lactation
- Previous radiotherapy of any kind which has resulted in irradiation of both kidneys and/or > 50% of the red bone marrow.
- Any other serious, uncontrolled medical or psychiatric condition including other advanced or metastatic malignant disease that, in the opinion of the investigator, precludes the patient from participation in the trial
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Inability or reluctance to adhere to the radiation safety instructions
- Previous treatment with PRRT for NET
See the full eligibility criteria
Who can join
- The subject has given written informed consent to participate in the study.
- Given the available, approved anti-tumor treatments and the specific characteristics of the patient and the tumor, the investigator judges 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
- Adequate hematological parameters as defined by: Hemoglobin > 90 g/L, platelets >100 x109/L, leukocytes > 3.0x109/L, neutrophils > 1.5 x109/L
- Adequate hepatic function as defined by ASAT/ALAT < 3 x ULN, bilirubin < 2 x ULN, albumin > 25 g/L.
- For women of child-bearing potential, highly effective contraception should be usedfrom the time of inclusion up to at least six months after the EOT visit. For details see appendix 5.
- For male subjects living with a woman of child-bearing potential, adequate contraception should be used from the time of inclusion up to at least six months after the EOT visit. Adequate male contraception methods are vasectomy, surgical or pharmacological castration, or the use of condom during heterosexual intercourse.
- Age ≥18 years
- ECOG performance status 0-1
- Life expectancy > 3 months.
- Presence of histologically confirmed, advanced, well-differentiated, inoperable NETof any primary tumor origin (except pheochromocytoma and paraganglioma) and any grade, with a maximum Ki67 of 50%
- SSTR-expression (mean SUV) in tumor lesions ≥ 2x mean SUV in normal liver on 68Ga-DOTA-PET performed ≤ 6 months prior to randomization. Due to partial volume effects, tumor lesions smaller than 1 cm on CT or MRI should not be used to evaluate this eligibility criterium.
- 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
What rules you out
- Pregnancy or lactation
- Previous radiotherapy of any kind which has resulted in irradiation of both kidneys and/or > 50% of the red bone marrow.
- Any other serious, uncontrolled medical or psychiatric condition including other advanced or metastatic malignant disease that, in the opinion of the investigator, precludes the patient from participation in the trial
- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- Inability or reluctance to adhere to the radiation safety instructions
- Previous treatment with PRRT for NET
- Concomitant systemic anti-tumor therapy other than SSA
- Participation or recent participation in a clinical study with an investigational product within 30 days of randomization.
- Known hypersensitivity to edotreotide, octreotide, capecitabine or any of the excipients included in the preparations.
- Contraindications for treatment with capecitabine: a. Severe arterial thromboembolic events (myocardial infarction,unstable angina pectoris, stroke) less than 6 months before inclusion. b. New York Heart Association (NYHA) Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure c. Previous serious or unexpected reactions to fluoropyrimidine treatment d. Known complete deficiency of dihydropyrimidine dehydrogenase (DPD) e. Recent or concomitant treatment with brivudine
- Discordance between CT/MRI/18F-FDG-PET and 68Ga-DOTA-PET, with evidence of tumor lesions without uptake on 68Ga-DOTA-PET
- Liver-directed therapy of metastases (i.e. radioembolization, chemoembolization, radiofrequency ablation, surgery, etc) < 4 weeks prior to randomization.
- Major surgery < 12 weeks prior to randomization.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.