Intratumoral holmium microspheres brachytherapy for patients with pancreatic cancer; a single center, non-randomized, feasibility study in an open surgical setting- the SLOTH1 study - SLOTH-1

Radboud Universitair Medisch Centrum0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Female or male aged 18 years and over.
•2. Diagnosis of primary borderline resectable pancreatic cancer by Dutch
•Pancreatic Cancer Group (DPCG) guidelines:
•3. 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.
•4. Life expectancy of 12 weeks or longer.
•5. World Health Organisation (WHO) Performance status 0-1.
•6. 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.
•7. Negative pregnancy test for women of childbearing potential.

•1. Radiation therapy within the last 4 weeks before the start of study therapy.
•2. Calcifications in the pancreas or tumour that are highly expected to
•obstruct the needle tract
•3. 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.
•4. Serum bilirubin > 250 µmol/l
•5. Leukocytes < 4.0 10^9/l and/or platelet count < 100 10^9/l.
•6. 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.
•7. 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.
•8. Pregnancy or breast feeding (women of child-bearing potential).
•9. Patients suffering from psychic disorders that make a comprehensive
•judgement impossible, such as psychosis, hallucinations and/or depression.
•10. Patients who are declared incompetent.

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