TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours W… (NCT04362436) | Clinical Trial Compass
CompletedPhase 2
TheraSphere Selective Internal Radiation Therapy (SIRT) as Treatment for Neuroendocrine Tumours With Liver Mets
United Kingdom24 participantsStarted 2019-02-05
Plain-language summary
This is an open label study for patients with inoperable metastatic neuroendocrine liver deposits to see whether treatment with Selective Internal Radiation Therapy (TheraSpheres) could lead to improved treatment response rates with acceptable toxicity (minimal serious adverse events reported). This research will also look at the progression free survival and quality of life of the patients who decide to join the study.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All patients must be discussed at a specialist hepatobiliary multi-disciplinary team meeting (MDT) and meet the following criteria:
* Histologically confirmed neuroendocrine tumour, with documented grade.
* \>18 years of age
* Patients may be on SSAs concurrently.Patients must have had at least one previous line of therapy
* Unresectable liver only or liver predominant metastases (typically involving \>25% but \<60% of the liver, and technically inoperable, or unfeasible secondary to medical comorbidity)
* Have measurable disease by RECIST 1.1 criteria
* Life expectancy of \>12 weeks
* Eastern Cooperative Oncology Group (ECOG) / World Health Organisation (WHO) Performance Status of 0-1
* Adequate liver function (bilirubin less than 34 umol/L in the absence of a reversible cause)
* Blood work: patients must have
* Platelet count of \> or = to 50x10\^9/L
* Hb of \> or = to 8.5g/dL
* Alanine Aminotransferase (ALT) and Aspartate transaminase (AST) \< 5 x Upper limit of normal (ULN)
* Serum creatinine \< 1.5 x ULN
* Internal Normalised Ration (INR) \< 2.0
* Patients with portal vein thrombosis may be considered, as determined at MDT (A compromised main portal vein as demonstrated on triple-phase CT scan unless selective or super-selective SIRT can be performed and the other safety criteria are fulfilled)
Exclusion Criteria:
Patients who meet any of the following exclusion criteria will NOT be considered eligible for this study.
* Clinically appa…
What they're measuring
1
Incidence of adverse events
Timeframe: Throughout study completion, up to 1 year
2
Define objective response rate (ORR)
Timeframe: Throughout study completion, up to 1 year