Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

Liver Cancer Clinical Trial

Official title:

Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607828
• Other study ID #: 0337-07-FB
• Secondary ID: P30CA036727
• Status: Completed
• Phase: N/A
• Start date: November 16, 2007
• Est. completion date: February 15, 2017

Study information

• Verified date: December 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

Inclusion Criteria:

• 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 weeksWBC = 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 PT, PTT, INR exists

Exclusion Criteria:

• No known 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

• 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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Radiation:
• stereotactic body radiation therapy
Undergo radiotherapy

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity as assessed by NCI CTCAE v3.0	Toxicity as assessed by NCI CTCAE v3.0	Up to 1 month after SRT
Primary	Maximum tolerated dose	Maximum tolerated dose	At least 1 month of observation after surgery