Percutaneous intratumoural holmium microspheres brachytherapy for patients with pancreatic cancer; a single centre, prospective safety and feasibility study - SLOTH-2a

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7月8日

适应症

试验速览

暂无简介。

•1. Female or male aged 18 years and over.
•2. Pathologically proven pancreatic adenocarcinoma, also known as pancreatic
•ductal adenocarcinoma.
•3. Patient is deemed ineligible for surgical resection of the pancreatic cancer:
•a. in accordance with consensus at the multidisciplinary meetings/discussions,
•b. and/or the patient refuses to undergo surgical resection out of personal
•4. Life expectancy of 16 weeks or longer.
•5. World Health Organisation (WHO) Performance status 0-1
•6. One or more measurable pancreatic tumours of at least 20 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. Chemotherapy within the last 2 weeks before the start of study therapy.
•3. Calcifications in the pancreas or tumour that are highly expected to
•obstruct the needle tract
•4. Any unresolved toxicity >= grade 3 from the National Cancer Institute (NCI),
•Common Terminology Criteria for Adverse Events (CTCAE version 5.0) from
•previous anti-cancer therapy.
•5. Leukocytes < 3.0 109/l and/or platelet count < 75 109/l.
•6. Kidney failure: Creatine > 165 µmol/l and/or eGFR < 60 ml/min/1,73m2
•7. Significant cardiac event 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.
•8. Patient is deemed ineligible for implantation of 166Ho by an expert panel
•(surgeon, nuclear medicine physician, interventional radiologist, radiologist,
•and researcher) due to tumour anatomy, nearby structures, patient status or a
•combination.
•9. Pregnancy or breast feeding (women of child-bearing potential).
•10. Patients suffering from psychic disorders that make a comprehensive
•judgement impossible, such as psychosis, hallucinations and/or depression.
•11. Patients who are declared incompetent.

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