Clinical trial NCT00607828: Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Official title: Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-06
Enrollment: 7
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
timeFrame: Up to 1 month after Stereotactic Radiation Therapy (SRT) treatment
Secondary outcomes:
measure: Response at 1-month Post SRT
timeFrame: Measured from first day of SRT to 1-month post SRT.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Chi Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: