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ProtocolTrial Name and Objective
071501

RTOG 1112: Randomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma

2.1 Primary Objective
2.1.1 To determine if SBRT improves overall survival in HCC patients treated with Sorafenib
2.2 Secondary Objectives
2.2.1 To determine the difference in time to progression (TTP) and progression-free survival (PFS) in
HCC patients treated with Sorafenib compared to SBRT followed by Sorafenib
2.2.2 To measure differences in toxicity in HCC patients treated with Sorafenib versus SBRT followed
by Sorafenib
2.2.3 To measure vascular thrombosis response post Sorafenib versus SBRT followed by Sorafenib
2.2.4 To measure differences in Health Related QOL and quality-adjusted survival in HCC patients
treated with Sorafenib compared to SBRT followed by Sorafenib
2.2.5 Collection of biospecimens for future correlative studies to investigate differences in potential
biomarkers in patients treated with Sorafenib versus SBRT followed by Sorafenib
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111109

COG AHEP0731: Treatment of Children with All Stages of Hepatoblastoma

1.1.2
Stage I hepatoblastoma (non-pure fetal histology [PFH]), non-small cell undifferentiated [SCU]) and Stage II (non-SCU) is a highly curable disease with 2 cycles of adjuvant cisplatin, 5-fluorouracil, and vincristine (C5V).

1.1.3
The addition of doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma will be feasible and associated with acceptable levels of toxicity.

1.1.4
The use of vincristine and irinotecan in an upfront window for children with high-risk, metastatic hepatoblastoma will improve the response rate in this group of children.

1.1.5
Referral for orthotopic liver transplant (OTL) is feasible in a cooperative group setting in children with hepatoblastoma designated as potentially unresectable following central surgical review and staging according to the PRE TEXT (Pretreatment Extent of Disease) grouping system.

1.2 Primary Aims

1.2.1
To estimate the EFS in children with Stage I (non-PFH, non-SCU) and Stage II (non SCU) hepatoblastoma treated with surgical resection followed by 2 cycles of C5V.

1.2.2
To determine the feasibility and toxicity of adding doxorubicin to the chemotherapy regimen of C5V for children with intermediate-risk hepatoblastoma.

1.2.3
To estimate the response rate to vincristine and irinotecan in previously untreated children with high-risk, metastatic hepatoblastoma.

1.2.4
To determine whether timely (between diagnosis and end of second cycle of chemotherapy) consultation with a treatment center with surgical expertise in major pediatric liver resection and transplant can be achieved in 70% of patients with potentially unresectable hepatoblastoma.

1.2.5
To foster the collection of tumor tissue and biologic samples to facilitate translational research and to provide data that may aid in risk-adapted approaches for subsequent clinical trials.
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