RAdiation SEgmentectomy With REsin Microspheres (RASEREM) Study
ConditionLiver Cancer, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara University
About this trial
Radiation segmentectomy (RS) refers to selective infusion of Y-90 microspheres to the tumor bearing hepatic segment of hepatic artery. Majority of the data on RS is based on the Glass microspheres experience. Due to different properties of Resin and Glass microspheres description of dose limits to the segment for effectiveness of treatments with Resin microspheres are needed.
Based on this background in this study it is aimed to evaluate the safety and efficacy of RS with resin microspheres in HCC patients. Secondly, it is planned to describe the dose limits for complete radiological response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years
Underwent RE as a RS intent (have single or <3 tumors in same or neighboring 2 segments) for the treatment of HCC or metastatic tumor to liver.
Presence of extrahepatic disease
Tumor size less than 8 cm
Disqualifiers
Presence of macrovascular invasion,
Presence of extrahepatic disease,
Cholangiocarcinoma or mixed HCC-cholangiocarcinoma
Not willing to attend follow-up visits.
Trial population
Study population will include the patients who will receive radioembolization for radiation segmentectomy intent for primary or secondary liver tumors
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Radiation Segmentectomy Group
Trial outcomes
Primary outcomes
1
Effectiveness of radiation segmentectomy
Evaluation of response with modified RECIST criteria
Time frame
3 months after treatmentSecondary outcomes
1
Safety of radioembolization in radiation segmentectomy intent
Evaluation of toxicity of radiation segmentectomy at the 3 month of treatment with CTCAE grading
Time frame
3 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ankara University
Lead sponsor
Sirtex Medical
Collaborator
Source ClinicalTrials.gov