Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma (NCT01005875) | Clinical Trial Compass
TerminatedNot Applicable
Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma
Stopped: Sponsor(Bayer)did not wish to continue with study due to slow accrual. Therefore, there is insufficient data and will not be any study results/outcomes.
United States5 participantsStarted 2009-11
Plain-language summary
This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child-Pugh class A or B7 cirrhosis.
* No prior radiation therapy to the upper right abdominal quadrant.
* Size of each tumor less than 6 cm.
* Three or less known lesions.
* More than 800 cc of uninvolved liver.
* Age \> 19 years old
* ECOG Performance Status 0 or 1
* Adequate bone marrow, liver and renal function as assessed by the following:
* Hemoglobin \> 8.5 g/dl
* Platelet count \> 50,000/mm3
* Total bilirubin \< 1.5 times ULN
* ALT and AST \< 2.5 times the ULN ( \< 5 x ULN for patients with liver involvement)
* Creatinine \< 1.5 times ULN
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
* Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
* INR \< 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR i…
What they're measuring
1
Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma