Status:
COMPLETED
Palliative Radiotherapy (RT) for Liver Metastases (Mets) and Hepatocellular Carcinoma (HCC)(COLD 4)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Hepatocellular Carcinoma
Hepatic Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Palliative radiotherapy is radiation treatment given to help reduce pain or discomfort, or other symptoms related to cancer. This is used commonly for cancer that has spread to the bones and brain, an...
Detailed Description
The liver is one of the most common sites with tumour involvement, including both primary and metastatic disease. Gastrointestinal tumours, breast, lung and melanoma are the most common primary sites ...
Eligibility Criteria
Inclusion
- Patients with hepatocellular carcinoma or hepatic metastases from a solid malignancy, unsuitable for radical therapy (including resection, transplant, conformal high dose radiotherapy), confirmed by biopsy or imaging
- Symptoms of hepatic pain, discomfort, nausea, or fatigue requiring palliation
- KPS\>60
- Expected survival of greater than 3 months
- Platelet count \> 25 bil/L, Hemoglobin \> 70 g/L, INR\<3, Bilirubin\<100 umol/L, AST \< 350 U/L or ALT\< 400 U/L
- Have signed an informed consent form approved by the Research Ethics Board (REB) at Princess Margaret Hospital
Exclusion
- Chemotherapy or novel drug within the past 2 weeks
- TACE(transarterial chemoembolization)within the past 1 month
- Plan for active treatment of the hepatocellular carcinoma or hepatic metastases, including TACE or RFA or ETOH injection
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00923897
Start Date
February 1 2007
End Date
September 26 2018
Last Update
June 18 2019
Active Locations (1)
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1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9