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NCT01730937 · OUTCOME

Overall Survival by Ethnicity

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer · Source last updated 2026-01-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

What was measured

NIH-required analysis. An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.

Analysis population: Eligible participants. Data were stratified by ethnicity.

Groups in this outcome

Sorafenib Alone

400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

SBRT Followed by Sorafenib

27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Sorafenib Alone92
SBRT Followed by Sorafenib85

Reported measurements

Hispanic or Latino

Analysis denominator · Participants

GroupSource count
Sorafenib Alone6
SBRT Followed by Sorafenib2
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone10.48Not reported4.7013.25Not reported
SBRT Followed by Sorafenib17.80Not reported6.8128.80Not reported
Not Hispanic or Latino

Analysis denominator · Participants

GroupSource count
Sorafenib Alone54
SBRT Followed by Sorafenib47
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone12.11Not reported8.6317.28Not reported
SBRT Followed by Sorafenib15.29Not reported10.9817.95Not reported
Unknown or Not Reported

Analysis denominator · Participants

GroupSource count
Sorafenib Alone32
SBRT Followed by Sorafenib36
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone13.16Not reported9.1417.60Not reported
SBRT Followed by Sorafenib15.85Not reported11.3121.24Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.70
        upper Limit
        13.25
        value
        10.48
      2. group Id
        OG001
        lower Limit
        6.81
        upper Limit
        28.80
        value
        17.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Hispanic or Latino
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.63
        upper Limit
        17.28
        value
        12.11
      2. group Id
        OG001
        lower Limit
        10.98
        upper Limit
        17.95
        value
        15.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Not Hispanic or Latino
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.14
        upper Limit
        17.60
        value
        13.16
      2. group Id
        OG001
        lower Limit
        11.31
        upper Limit
        21.24
        value
        15.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Unknown or Not Reported
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      85
    units
    Participants
description
NIH-required analysis. An event for overall survival (OS) is death due to any cause. Survival time is defined as time from randomization to the date of death or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 153 deaths were reported.
dispersion Type
90% Confidence Interval
groups
  1. description
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Sorafenib Alone
  2. description
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    SBRT Followed by Sorafenib
param Type
MEDIAN
population Description
Eligible participants. Data were stratified by ethnicity.
reporting Status
POSTED
time Frame
From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
title
Overall Survival by Ethnicity
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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Preserved source evidence · Not medical advice