Radioactive Holmium Microspheres for the Treatment of Unresectable Liver Metastases (HEPAR 2)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by UMC Utrecht.
Recruitment status was Recruiting
Information provided by (Responsible Party):
B.A. Zonnenberg, UMC Utrecht
First received: June 1, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
Radioembolisation is a known method for the treatment of liver tumors and or livermetastases. Currently small beadlets called microspheres are used that are loaded with the beta radiation emitting Yttrium-90. Holmium-166 microspheres have different physical characteristics including good visualisation in gammacameras due to the gamma emission. Because of the higher specific activity higher radiation doses to the liver will be used compared to the standard Yttrium treatment. It is hypothesized that higher doses of irradiation have an improved antitumor effect.
Device: Holmium-166 polylactic microspheres
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Radioactive Holmium Microspheres for the Treatment of Patients With Unresectable Liver Metastases; a Single Center, Interventional, Non-randomized, Phase II (HEPAR II) Trial
Primary Outcome Measures:
Secondary Outcome Measures:
- Toxicity according CTC v 4 criteria [ Time Frame: Clinical evaluation after 1,3,6,9,12,24,36,52 weeks ] [ Designated as safety issue: Yes ]
Clinical evaluation and laboratory testing after week 1,3,6,9,12,24,36,52
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Device: Holmium-166 polylactic microspheres
Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
List of inclusion criteria:
- 1. Patients must have given written informed consent.
- 2. Female or male aged 18 years and over.
- 3. Diagnosis of metastatic malignancy to the liver and no detectable malignant disease outside the liver or diagnosis of metastatic malignancy to the liver with limited disease outside the liver (i.e. liver-dominant disease) defined as the sum of the diameters of all metastases in the liver to be more than 200% of the sum of the diameters of all soft tissue lesions outside the liver.
- 4. Patient is not amenable for standard therapies (other than radioembolisation) or patient refuses standard therapies for reasons of toxicity
- 5. Life expectancy of 12 weeks or longer.
- 6. World Health Organisation (WHO) Performance status 0-2 (see Appendix III).
List of exclusion criteria:
- 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 (CTCAE version 4.0, see Appendix II) 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 < 4.0 109/l and/or platelet count < 150 109/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 breast feeding (women of child-bearing potential).
- Patients suffering from diseases with a increased chance of liver toxicity, such as primary biliary cirrhosis or xeroderma pigmentosum.
- 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 radioembolisation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01612325
|Department of Radiology University Medical Center Utrecht
|Utrecht, Netherlands, 3584CX |
|Principal Investigator: Bernard A Zonnenberg, MD, PhD |
|Sub-Investigator: Maurice A van den Bosch, Prof. MD PhD |
||Bernard Zonnenberg, MD, PhD
||UMCU Utrecht Netherlands
||Martin Hendriks, MD, PhD
||UMCU Utrecht, Netherlands
Smits ML, Nijsen JF, van den Bosch MA, Lam MG, Vente MA, Huijbregts JE, van het Schip AD, Elschot M, Bult W, de Jong HW, Meulenhoff PC, Zonnenberg BA. Holmium-166 radioembolization for the treatment of patients with liver metastases: design of the phase I HEPAR trial. J Exp Clin Cancer Res. 2010 Jun 15;29:70. doi: 10.1186/1756-9966-29-70.
||B.A. Zonnenberg, principal investigator, UMC Utrecht
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 1, 2012
||June 1, 2012
||Netherlands: Dutch Health Care Inspectorate
Keywords provided by UMC Utrecht:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases