Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer (SLOTH-1)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2022
  • participants needed
    6
  • sponsor
    Radboud University Medical Center
Updated on 22 March 2022
celiac
resectable pancreatic cancer

Summary

This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.

Details
Condition Pancreas Cancer
Treatment QuiremSpheres®
Clinical Study IdentifierNCT05191498
SponsorRadboud University Medical Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female or male aged 18 years and over
Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines
1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. Or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion
iii. The discussion on resectability has to be made in consensus at
multidisciplinary meetings/discussions and may overrule the above criteria (i
ii)
Patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible
Life expectancy of 12 weeks or longer
World Health Organisation (WHO) Performance status 0-1
One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria
Negative pregnancy test for women of childbearing potential

Exclusion Criteria

Radiation therapy within the last 4 weeks before the start of study therapy
Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0) grade 2 from previous anti-cancer therapy
Leukocytes < 4.0 109/l and/or platelet count < 100 109/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
Patient is deemed ineligible for implantation of 166Ho by an expert panel (surgeon, nuclear medicine physician and researcher) due to tumour anatomy or nearby structures
Pregnancy or breast feeding (women of child-bearing potential)
Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression
Patients who are declared incompetent
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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