Status:
COMPLETED
Stereotactic Body Radiation Therapy (SBRT) Hepatocellular Carcinoma (COLD 2)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepa...
Detailed Description
From July 2003 to May 2007, over 40 patients with hepatocellular carcinoma participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating hepatocellular c...
Eligibility Criteria
Inclusion
- Confirmed pathologically, 2)diagnosed by showing vascular enhancement of the lesion on at least two imaging techniques, or 3) diagnosed by showing vascular enhancement on a single technique if the AFP is greater than 200, in the setting of cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus conference guidelines).
- Either 1) the tumour must be unresectable, based on the opinion of an experienced surgeon specializing in hepatic resection, or 2) the patient Phase II SBRT HCC 13 must be medically inoperable, or 3) extra-hepatic metastases must be present (making hepatic surgery an inappropriate treatment option).
- Karnofsky performance status (KPS) \> 60 (Appendix II)
- Age: 18 years or older. Both male \& female patients of all races can be included in this study. Female patients within reproductive years may not be, nor become, pregnant during participation in this study
- Patients must have recovered from the effects of previous therapy.
- Maximal tumor size of 15 cm.
- Adequate organ function as assessed as follows:
- Hemoglobin \> 90 g/L
- Absolute neutrophil count \> 1.0 bil/L
- Platelets \> 50 bil/L
- Bilirubin \< 4.0 times upper range of normal
- INR \< 1.5 or correctable with vitamin K (unless patient is on coumadin in which case higher levels are acceptable)
- AST or ALT \< 6.0 times upper range of normal
- Child's A 5-6 liver score or Child B 7-8 liver score, which is only permitted if the maximal tumor size is 10 cm
- Previous liver resection or ablative therapy is permitted.
- Life expectancy \> 3 months
- The volume of uninvolved must be at least 700 cc
- Up to five discrete liver tumors
- Patients must have signed a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative.
Exclusion
- Patients with active hepatitis or encephalopathy related to liver failure
- Prior radiation therapy to the right upper abdomen, precluding reirradiation of the liver. That is, any previous radiation therapy in which a mean dose to the liver of 15 Gy in conventional fractionation was delivered, or previous doses to critical normal structures that would make re-irradiation unsafe. The PI should be called if there is any question of safety of re-irradiation.
- Eligible for RFA or alcohol ablation
- Eligible for TACE
- Prior uncontrolled, life threatening malignancy within the six months.
- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and acceptable methods of contraception are warranted.
- Previous gastric, duodenal or variceal bleed within the past 2 months.
- Commencement of coumadin use within the past 3 months.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00914355
Start Date
August 1 2007
End Date
December 8 2020
Last Update
October 6 2021
Active Locations (1)
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1
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9