Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer

NCT ID: NCT00607828

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-16
• Study Completion Date: 2017-02-15

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 send x-rays directly to the tumor and cause less damage to normal tissue.

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 send x-rays directly to the tumor and cause less damage to normal tissue. Participants must have pathologically confirmed hepatocellular carcinoma with at least one tumor with a maximum diameter of ≤ 8 cm and must have Karnofsky performance status ≥ 60% and a life expectancy of at least 12 weeks.

The primary objective is determining the safety of hypofractionated stereotactic radiotherapy in patients with advanced hepatocellular carcinoma by using toxicity profiles described in the Common Terminology Criteria for Adverse Events (CTCAE) V.3.0. Secondary objectives are determining the maximal tolerable SRT dose, objective tumor response rate, the value of 4-Dimensional Computed Tomography (4DCT) in liver cancer planning, and the value of breath gating in liver cancer stereotactic body radiotherapy (SBRT). After completion of study therapy, participants are followed at 1 and 3 months.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hypofractionated stereotactic radiotherapy (SRT)

All patients who have had successful implantation of a liver marker will undergo a 4D CT scan for planning SRT. Following transfer to the treatment planning system, the CT scan may be correlated by imaging fusion with MRI for contouring integrated tumor volume (ITV). The planning target volume (PTV) will be defined as ITV plus individualized margins which are determined by a 4D CT scan. Novalis with 6MV photons will be used for imaging guided SRT. Cohorts of 3-6 patients will receive SRT at daily doses of 8, 10, 12, 14 Gy within 2 weeks. The starting daily dose level will be 10 Gy. The marker will be localized by orthogonal X-ray to ensure reproducibility. A continuous respiratory gating will be accomplished with ExacTrac Adaptive Gating system if the required planning target margin is larger than 1 cm based on the 4D CT data.

Group Type: EXPERIMENTAL

stereotactic body radiation therapy

Intervention Type: RADIATION

Undergo radiotherapy

Interventions

stereotactic body radiation therapy

Undergo radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

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 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 Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi Lin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA036727

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0337-07-FB

Identifier Type: -

Identifier Source: org_study_id