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

Completed

Conditions: Pancreatic cancer
Pancreatic carcinoma
10017990
10017991
10017998

Registration Number: NL-OMON49772

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is to establish the feasibility of intratumoral implantation<br /><br>of 166Ho-PLLA-MS by evaluating the average tumour absorbed dose in Gy<br /><br>calculated on SPECT. Microsphere distribution, absorbed dose and non-target<br /><br>absorbed dose are also analysed using MRI and CT. Additionally, safety,<br /><br>expressed in Common Terminology Criteria for Adverse Events (CTCAE v4.0) events<br /><br>grade >= 3 deemed possibly, probably or definitely related to the implantation<br /><br>procedure or medical device implanted, is monitored. Tumor response is<br /><br>evaluated according to the RECIST 1.1 guidelines at 3 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Safety, expressed in Common Terminology Criteria for Adverse Events (CTCAE<br /><br>v4.0) events grade >= 3 deemed possibly, probably or definitely related to the<br /><br>implantation procedure or medical device implanted.<br /><br>• To evaluate the average tumour absorbed dose in Gy calculated on MR images.<br /><br>• To evaluate the average tumour absorbed dose in Gy quantified using CT images<br /><br>• To evaluate the distribution of absorbed dose throughout the 3D target area<br /><br>(dose coverage).<br /><br>• To evaluate non-target dose deposition (within the pancreas and outside the<br /><br>pancreas).<br /><br>• To evaluate the implant efficiency.<br /><br>• To evaluate tumour response according to RECIST 1.1 at 3 months.<br /><br>• The implant experience using a questionnaire for the performing physician(s).<br /><br>• To evaluate radiation safety aspects for operators.</p><br>