Status:
COMPLETED
Sorafenib-RT Treatment for Liver Metastasis (SLIM)
Lead Sponsor:
University Health Network, Toronto
Conditions:
Liver Metastasis
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Cancers that have spread to the liver from the primary cancer location (liver metastases) that cannot be removed surgically (unresectable) can be treated with chemotherapy and/or radiation therapy. Pr...
Detailed Description
In this study, Stereotactic Body Radiation Therapy(SBRT) and Whole Liver Radiotherapy (WLRT) will be used concurrently with sorafenib at 3 different dosages to determine the tolerability and efficacy ...
Eligibility Criteria
Inclusion
- Histologically confirmed liver metastases
- Largest burden of disease should be hepatic if there's extrahepatic disease exists
- Tumour should be medically inoperable
- Patient have a life expectancy of at least 3 months and a KPS performance status of at least 60%.
- Patient should be 18 years of age or older
- Patient should have adequate organ function
- Patient have Creatinine ≤ 2 times upper limit of normal range
- Patient recovered from the effects of prior therapy
- Patient (or person representing the patient) should be able to give informed consent
- Patient have Child's A score (5 or 6) score
- For women of childbearing age, birth control is being used and the pregnancy test is negative
Exclusion
- No major surgery in the past 4 weeks.
- No previous use of sorafenib previously.
- Patient should not have or is receiving systemic therapy or investigational agents within 2 weeks of radiotherapy
- No previous upper abdominal radiation therapy to the liver.
- No serious medical conditions that may be aggravated by treatment, including but not limited to: myocardial infarction within 6 months, congestive cardiac failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled hypertension, uncontrolled psychotic disorders,serious infections, active peptic ulcer disease, active liver disease or previous stroke.
- Patients who are infected with human immunodeficiency virus (HIV), should not be receiving combination anti-retroviral therapy
- No clinically significant liver failure (i.e. encephalopathy or ascites found clinically).
- No thrombolytic therapy within 4 weeks or are they receiving other anticoagulant therapy.
- No underlying cirrhosis with Child's B or C score.
- No history of uncontrolled, life threatening malignancy within the past 6 months.
- Patient should not have a variceal bleed or other gastrointestinal bleed in the past 2 months.
- No brain metastases
- Patient should not be pregnant.
- Patients on Rifampin, St. John's Wort, Phenytoin, Carbamazepine, Phenobarbital, or Chronic use (more than 4 weeks) of dexamethasone
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00892424
Start Date
November 1 2008
End Date
September 8 2020
Last Update
September 10 2020
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2M9