Response of Hepatic Tumors to Radioembolization (RESRAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01775280
First received: January 22, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

The study enrolls patients with non-resectable or borderline resectable hepatocellular carcinoma (HCC), intraheaptic choalngiocarcinoma (IHCC) or colorectal cancer metastasis. Patients are not a candidates for liver transplantation and have only limited extrahepatic disease. All patients are treated with radioembolization. Primary endpoint is the percentage of patients that can be downstaged to resectability.

Secondary endpoints are radiologic response to radioembolization,tissue response to radiomembolization and systemic immune response and intra-tumoral T-cell response to radioembolization.

  • Trial with radiotherapy

Condition Intervention Phase
Hepatocellular Carcinoma
Intrahepatic Cholangiocarcinoma
Liver Metastasis
Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radiologic, Histologic and Immunologic Response to Radioembolization of Hepatic Tumors

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Primary endpoint ist the percentage of patients that can be downstaged to resectability [ Time Frame: 2012 to 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histologic response to radioembolization [ Time Frame: 2012 to 2015 ] [ Designated as safety issue: No ]
    Resected specimen will be examined for changes related to radioembolization like endothelial damage, necrosis, fibrosis

  • Immunological response to radioembolization [ Time Frame: 2012 to 2015 ] [ Designated as safety issue: No ]

    Circulating T-cells and tissue based T-cells will be examined for their response to tumor antigens, clonal proliferation.

    Serologic response to tumor antigens will be examined



Estimated Enrollment: 24
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radioembolization
Radioembolization using Yttrium-90 microspheres using a transarterial approach
Radiation: Injection of Ytttrium-90 microspheres into the hepatic artery
INjection of Y-90 particles into the hepatic artery using endovascular access

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria: - Patients already considered for radioembolization fulfil criteria to be included in the study. If radioembolization is not considered by the tumor board, inclusion in the study should not be considered.

- Non-resectable or borderline resectable liver tumors (HCC, CRCM or CCC) as as-sessed by a multidisciplinary tumor-board. Non-resectability or borderline resectablily is based closeness to essential nonresectable structures (f.e. the portal vein bifurca- tion or hepatic vein trifurcation) or insufficient liver volume after resection, general performance status of the patient.

Chemotherapy (mostly applicable to CRCM) should be termininated at least 4 weeks prior to enrolling patients in the study.

  • Concomitant manoevers to manipulate liver volume like portal vein embolization or ligation and two-stage resections are allowed
  • Male or female patients 18-99 years of age
  • Presentation of the case at the Multidisciplinary Meeting attended by hepatobiliary surgeons, oncologists, hepatologists and radiologists
  • Written informed consent given by the patient
  • Adequate liver function or kidney function tests, including any of the following. It is possible to perform endoscopic or percutaneous stent placement to achieve normal-isation of laboratory parameters.
  • Women who are not breastfeeding and are using effective contraception if sexually active, who are not pregnant and agree not to become pregnant during the 12 months thereaf-ter. A negative pregnancy test before inclusion into the trial is required for women < 50 years. Men who agree not to father a child during participation in the trial or during the 12 months thereafter.
  • Effective contraception

Patient compliance and geographic proximity

Exclusion criteria: -Patients with no clinical indications for radioembolization (resectable tumors, no need for downsizing)

  • contraindications on ethical grounds,
  • women who are pregnant or breast feeding,
  • significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardi-ovascular disease, etc) as based on above mentioned labaratory values or preopera-tive cardiac assessment making the patient unsuitable for major surgery known or suspected non-compliance, drug or alcohol abuse, enrolment into a clinical trial within last 4 weeks, extrahepatic tumor burden, as evaluated by PET/CT or chest CT. Potentially resectable small lung nodules or hilar lymphadenopathy by CT or PET in case of MCRC mandate systemic chemotherapy prior to enrolment into this trial if not already performed. The patient may be en-rolled into this trial to be downstaged by radioembolization after finishing systemic chemotherapy.
  • Anatomic variant in arteriogram which prevents selective delivery of the chemother-apy to the liver (discussed within group of principal investigators)
  • Life expectancy < 3 months
  • Candidacy for liver transplantation in the case of HCC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775280

Contacts
Contact: Erik Schadde, MD erik.schadde@usz.ch

Locations
Switzerland
University Hospital Zurich, Divisions of Visceral Surgery and Nucelar Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Erik Schadde, MD University Hospital Zurich, Division of Visceral and Transplant Surgery
Principal Investigator: Niklaus Schaefer, MD University Hospital Zurich, Division of Nuclear Medicine
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01775280     History of Changes
Other Study ID Numbers: USZ-ZH-VIS-RESRAD
Study First Received: January 22, 2013
Last Updated: January 22, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Cholangiocarcinoma
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014