Status:
COMPLETED
Stereotactic Radiotherapy (SRT) Liver (COLD 1)
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
American Society of Clinical Oncology
Conditions:
Liver Neoplasms
Neoplasm Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
A minority of patients with colorectal liver metastases and hepatobiliary cancer (primary liver cancer) are candidates for surgery, but there are no curative treatment options for these patients. Thei...
Eligibility Criteria
Inclusion
- Primary hepatobiliary confirmed pathologically or via imaging
- Liver metastases from colorectal cancer or other solid malignancy, confirmed pathologically
- New radiographic liver lesions most consistent with metastases, in a patient with previously pathologically proven solid malignancy and a previously negative liver contrast CT or MRI
- The tumor must be unresectable or the patient must be medically inoperable or extra-hepatic metastases must be present
- Karnofsky performance status (KPS) \> 60
- Age \> 18 years
- Patients must have recovered from the effects of previous surgery, radiotherapy or chemotherapy
- Chemotherapy must be completed at least 2 weeks prior to radiation therapy or not planned to be administered for at least 2 weeks
- Adequate organ function as assessed as follows:Hemoglobin \> 90 g/L, Absolute neutrophil count \> 1.5 bil/L, Platelets \> 80,000 bil/L, Bilirubin \< 3.0 times upper range of normal, INR \< 1.3 or correctable with vitamin K, AST or ALT \< 6.0 times upper range of normal, Creatinine \< 200 umol/L (other than patients who are having dialysis or already have dialysis lines in place for future dialysis for renal failure. These patients may be treated on study with no upper limit on their creatinine.)
- Child A liver score
- Previous liver resection or ablative therapy is permitted.
- Life expectancy \> 3 months
- Multiple metastases are permitted (volume of uninvolved must be at least 800 cc, and the maximal effective liver volume that may be treated is 80%.
- Informed consent form
Exclusion
- Patients with active hepatitis or clinically significant liver failure
- Prior radiation therapy to the right upper abdomen, precluding re-irradiation of the liver. (Prior pelvic radiation is permitted, as long as no overlap between pelvic and liver radiation fields occurs.)
- Prior uncontrolled, life threatening malignancy within the past year.
- Gross (clinically apparent) ascites.
- Pregnancy is not permitted, and in women of child bearing age, a pregnancy test and birth control are warranted.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2020
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00152906
Start Date
July 1 2003
End Date
July 10 2020
Last Update
August 14 2020
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9