Status:
COMPLETED
Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
19-120 years
Phase:
NA
Brief Summary
This is a phase I trial studying the side effects and best dose of stereotactic radiation therapy (SRT) in treating patients with advanced liver cancer. Stereotactic radiation therapy may be able to s...
Detailed Description
This is a phase I trial studying the side effects and best dose of stereotactic radiation therapy (SRT) in treating patients with advanced liver cancer. Stereotactic radiation therapy may be able to s...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)
- Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be accurately measured by CT scan or MRI according to RECIST and must have a maximum diameter ≤ 8 cm
- Child-Pugh class A-B cirrhotic status
- Karnofsky performance status 60-100%
- Life expectancy ≥ 12 weeks
- White blood cell count (WBC) ≥ 2,000/μL
- Platelet count ≥ 60,000/mm³
- Hemoglobin ≥ 8.5 g/dLINR ≤ 2.3
- More than 6 months since prior myocardial infarction
- Prior systemic chemotherapy allowed
- At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation)
- Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in Prothrombin time (PT/INR) and partial thromboplastin time (PTT) exists
Exclusion
- No known central nervous system (CNS) tumors, including metastatic brain disease
- No malignancy within the past 3 years that is distinct in its primary site or histology from HCC, except for carcinoma in situ of the cervix, treated basal cell carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer that has been curatively treated \> 3 years prior to study entry
- No renal failure requiring hemodialysis or peritoneal dialysis
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection \> grade 2
- New York Heart Association (NYHA) class II-IV congestive heart failure
- Active coronary artery disease
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- Uncontrolled hypertension
- Condition that could jeopardize the safety of the patient or study compliance
- No history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
- No condition that would prevent the patient from undergoing marker implantation
- Not pregnant or nursing/negative pregnancy test
- No substance abuse, medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results
- No prior radiotherapy to the liver
Key Trial Info
Start Date :
November 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00607828
Start Date
November 16 2007
End Date
February 15 2017
Last Update
November 4 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6805