Holmium-166-radioembolization in NET After Lutetium-177-dotatate; an Efficacy Study (HEPAR_Plus)
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|ClinicalTrials.gov Identifier: NCT02067988|
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : June 17, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Device: Holmium-166 microspheres hepatic radioembolization.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Hepatic Holmium-166-radioembolization in Patients With Unresectable Liver Metastases of Neuroendocrine Origin, Who Have Been Treated With Lutetium-177-dotatate|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||September 1, 2019|
|Actual Study Completion Date :||September 1, 2019|
Experimental: Treatment arm
Holmium-166 microspheres hepatic radioembolization, adjuvant to systemic 177Lu-dotatate.
Device: Holmium-166 microspheres hepatic radioembolization.
Holmium-166 microspheres hepatic radioembolization.
- Response (RECIST 1.1 Partial plus complete) [ Time Frame: 3 months ]To evaluate efficacy of adjuvant 166Ho-radioembolization (166Ho-RE) after systemic 177Lu-dotatate in a non-comparative phase II study
- Quality of Life (QoL) [ Time Frame: 3 months ]To evaluate QoL using EORTC questionnaire. The impact of treatment on QoL will be compared to tumour response, and other parameters. A questionnaire in the patient's native language will be provided.
- Biodistribution [ Time Frame: 3 months ]To evaluate biodistribution using CT and quantitative SPECT.
- Dosimetry [ Time Frame: 3 months ]To evaluate dosimetry using CT and quantitative SPECT. The imaging protocol after injection of 166Ho-PLLA-MS will consist of a dual isotope fusion SPECT/CT protocol.
- AD Adverse events [ Time Frame: 1 year ]To establish the safety and toxicity profile of treatment with 166Ho-microspheres as an adjuvant treatment after 177Lu-dotatate. This profile will be established using CTCAE (incl. SAE) methodology (CTCAE version 4.03).
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients must have given written informed consent.
- Female or male aged 18 years and over.
- Confirmed histological diagnosis NET, including bronchial carcinoids, and metastatic malignancy with liver metastases without standard therapeutic options for treatment including chemotherapy or surgery.
- Patients must have been treated with 4 cycles of 200 mCi 177Lu-dotatate, the last cycle within 8-12 weeks of 166Ho-RE.
- Life expectancy of 12 weeks or longer.
- World Health Organisation (WHO) Performance status 0-2.
- Liver disease with three or more measurable liver lesions according to the RECIST 1.1 criteria.
- Negative pregnancy test for women of childbearing potential.
- Brain metastases or spinal cord compression, unless irradiated at least 4 weeks prior to the date of the experimental treatment and stable without steroid treatment for at least 1 week.
- Radiation therapy within the last 4 weeks before the start of study therapy.
- The last dose of prior chemotherapy has been received less than 4 weeks prior the start of study therapy.
- Major surgery within 4 weeks or incompletely healed surgical incision before starting study therapy.
- Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events grade 2 from previous anti-cancer therapy.
- Serum bilirubin > 1.5 x Upper Limit of Normal (ULN).
- Glomerular filtration rate <35 ml/min, determined according to the Modification of Diet in Renal Disease formula.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 5 x ULN.
- Leukocytes < 3.0 x 109/l and/or platelet count < 100 x 109/l.
- Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- Pregnancy or nursing (women of child-bearing potential).
- Patients suffering from diseases with an increased chance of liver toxicity.
- Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- Patients who are declared incompetent.
- Previous enrolment in the present study or previous treatment with RE.
- Female patients who are not using an acceptable method of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation) OR are less than 1 year postmenopausal or surgically sterile during their participation in this study (from the time they sign the consent form) to prevent pregnancy.
- Male patients who are not surgically sterile or do not use an acceptable method of contraception during their participation in this study (from the time they sign the consent form) to prevent pregnancy in a partner.
- Patients with abnormalities of the bile ducts (such as stents) with an increased chance of infections of the bile ducts (papillotomy and cholecystectomy are allowed). Or evidence of extensive portal hypertension, splenomegaly, ascites or active hepatitis (B and/or C).
- Body weight over 150 kg.
- Severe allergy for i.v. contrast (Visipaque®), used for CT evaluation, pre-treatment angiography and treatment angiography.
- Liver tumour involvement ≥70% as quantified on CT.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067988
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Marnix G Lam, MD, PhD||UMC Utrecht, The Netherlands|
|Responsible Party:||Marnix Lam, MD, PhD, UMC Utrecht|
|Other Study ID Numbers:||
|First Posted:||February 20, 2014 Key Record Dates|
|Last Update Posted:||June 17, 2020|
|Last Verified:||June 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
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