Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Conditions
Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stereotactic body radiation therapy
Type: Radiation
Overall Status
Recruiting
Summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with advanced liver cancer.
Detailed Description
OBJECTIVES:

Primary

- To determine the safety of hypofractionated stereotactic radiotherapy (SRT) in patients with advanced hepatocellular carcinoma.

Secondary

- To determine the maximum tolerated dose of SRT in these patients.

- To determine the objective tumor response rate in terms of the percentage of tumor size change on CT, percentage of intensity change on MRI, and the percentage of change in alfa fetoprotein in patients treated with this therapy.

- To determine the value of 4-dimensional CT in liver cancer planning in terms of the extent of liver motion (three dimensionally) and the percentage of patients requiring breath gating due to the amplitude of organ motion exceeding 1 cm in any dimension.

- To determine the value of breath gating in liver cancer SRT in terms of the success rate of breath gating and the percentage of treatment time prolongation secondary to the gating.

OUTLINE: Patients undergo hypofractionated stereotactic radiotherapy once daily on days 1-5.

After completion of study therapy, patients are followed at 1 and 3 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- 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

- No known CNS tumors, including metastatic brain disease

- Child-Pugh class A-B cirrhotic status

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Life expectancy ≥ 12 weeks

- WBC ≥ 2,000/μL

- Platelet count ≥ 60,000/mm³

- Hemoglobin ≥ 8.5 g/dL

- INR ≤ 2.3

- 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

- 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

- More than 6 months since prior myocardial infarction

- 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

PRIOR CONCURRENT THERAPY:

- 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)

- No prior radiotherapy to the liver

- Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided that no prior evidence of underlying abnormality in PT, PTT, INR exists
Location
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Status: Recruiting
Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ - 800-999-5465
Start Date
November 2007
Sponsors
University of Nebraska
Source
University of Nebraska
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page