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Rtog 1112 Protocol Summary

This clinical trial compared stereotactic body radiation therapy (SBRT) followed by sorafenib to sorafenib alone in patients with hepatocellular carcinoma (HCC). The primary goal was to see if SBRT plus sorafenib improved overall survival more than sorafenib alone. Secondary goals included comparing progression-free survival, liver toxicity, and quality of life between the two groups. The researchers found that SBRT plus sorafenib led to improved overall survival, progression-free survival, and quality of life compared to sorafenib alone, especially at the 6-month follow up.

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120 views

Rtog 1112 Protocol Summary

This clinical trial compared stereotactic body radiation therapy (SBRT) followed by sorafenib to sorafenib alone in patients with hepatocellular carcinoma (HCC). The primary goal was to see if SBRT plus sorafenib improved overall survival more than sorafenib alone. Secondary goals included comparing progression-free survival, liver toxicity, and quality of life between the two groups. The researchers found that SBRT plus sorafenib led to improved overall survival, progression-free survival, and quality of life compared to sorafenib alone, especially at the 6-month follow up.

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RTOG 1112: Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation

Therapy Followed By Sorafenib in Hepatocellular Carcinoma

This clinical protocol was established to answer some of the questions about the use of
Stereotactic Body Radiation Therapy (SBRT) in conjunction with Sorafenib in the treatment of
Hepatocellular Carcinoma (HCC). The primary focus of this clinical trial was to see if this new
treatment method was more effective in extending the overall survival and quality of life of
patients suffering from HCC when compared to the previous standard of care. Secondary
objectives of this clinical trial sought to compare the time to progression of the disease between
the two arms, to measure the levels of liver toxicity experienced between each group, and to
determine if the new treatment method could replace what was accepted as the standard. The
goal was to improve survival and quality of life, while simultaneously reducing adverse effects to
the at-risk organs and to preserve liver function. The researchers hypothesized that SBRT
followed by sorafenib will improve survival of HCC patients compared to sorafenib alone. In
order for a patient to be included in this study, they must have been diagnosed with HCC within
180 days of their entry into the trial. Participants were also over the age of 18 years, had
measurable hepatic disease and/or presence of vascular tumor thrombosis on CT/MRI within 28
days of registration. They must also have had at least one solid liver tumor that measured more
than 1 cm in the setting of cirrhosis or hepatitis B or C without cirrhosis.1 The clinical protocol
defined the CTV to be equivalent to the GTV with no expansion, and this volume should be
surrounded by a 0.4-1.0 cm PTV margin. As stated in the protocol, 95 percent of this structure
should be covered by the prescription dose (27.5-50 Gy in 5 fractions). The researchers stated
that the highest dose to the PTV that maintains normal tissue constraints should be used. IMRT
was the preferred treatment method, while 3D conformal therapy was permitted.
For this clinical trial, the primary endpoint was overall survival of the patient. Other
secondary endpoints included time of disease progression or lack of progression, toxicity, and an
improvement of the patients’ quality of life. These were the determining factors upon which the
hypothesis was tested. The researchers found that compared to Sorafenib alone, SBRT use
improved overall survival, progression free survival, and quality of life. This effect was
especially significant in the 6 month follow up where SBRT seemed to demonstrate a more long
lasting effect.
References:

1. Dawson LA, Winter K, Knox J, et al. NRG/RTOG 1112: Randomized phase III study of
Sorafenib vs. stereotactic body radiation therapy (SBRT) followed by sorafenib in hepatocellular
carcinoma (HCC) (NCT01730937). International Journal of Radiation
Oncology*Biology*Physics. 2022;114(5):1057. doi:10.1016/j.ijrobp.2022.09.002

2. About Us. RTOG. Accessed July 25, 2023. https://www.rtog.org/About-Us.

3. Bujold A, Massey CA, Kim JJ, et al. Sequential phase I and II trials of stereotactic body
radiotherapy for locally advanced hepatocellular carcinoma. Journal of Clinical Oncology.
2013;31(13):1631-1639. doi:10.1200/jco.2012.44.1659

4. Sorafenib added to SBRT improves survival in hepatocellular carcinoma. ASCO Daily News.
January 23, 2023. Accessed July 25, 2023.
https://dailynews.ascopubs.org/do/sorafenib-added-sbrt-improves-survival-hepatocellular-carcino
ma.

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