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About
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.
Full 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.
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Inclusion criteria
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:
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
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7 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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