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NCT01730937 · OUTCOME

Overall Survival by Race

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 race.

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

American Indian or Alaska Native

Analysis denominator · Participants

GroupSource count
Sorafenib Alone1
SBRT Followed by Sorafenib0
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone10.65Not reportedNANALower and upper confidence bounds cannot be estimated because the analysis includes only one subject.
Asian

Analysis denominator · Participants

GroupSource count
Sorafenib Alone23
SBRT Followed by Sorafenib18
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone12.30Not reported4.6017.60Not reported
SBRT Followed by Sorafenib18.23Not reported11.3126.76Not reported
Native Hawaiian or Other Pacific Islander

Analysis denominator · Participants

GroupSource count
Sorafenib Alone0
SBRT Followed by Sorafenib1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
SBRT Followed by Sorafenib2.10Not reportedNANALower and upper confidence bounds cannot be estimated because the analysis includes only one subject.
Black or African American

Analysis denominator · Participants

GroupSource count
Sorafenib Alone5
SBRT Followed by Sorafenib3
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone7.35Not reported3.55NAUpper confidence bound could not be estimated because the upper confidence limit for survival did not cross 50%
SBRT Followed by Sorafenib20.35Not reported10.9429.76Not reported
White

Analysis denominator · Participants

GroupSource count
Sorafenib Alone58
SBRT Followed by Sorafenib59
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone12.03Not reported10.3214.70Not reported
SBRT Followed by Sorafenib14.70Not reported11.2120.28Not reported
Unknown or not reported

Analysis denominator · Participants

GroupSource count
Sorafenib Alone5
SBRT Followed by Sorafenib4
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib Alone22.88Not reported13.08NAUpper confidence bound could not be estimated because the upper confidence limit for survival did not cross 50%
SBRT Followed by Sorafenib11.94Not reported5.3439.22Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Lower and upper confidence bounds cannot be estimated because the analysis includes only one subject.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        10.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    American Indian or Alaska Native
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.60
        upper Limit
        17.60
        value
        12.30
      2. group Id
        OG001
        lower Limit
        11.31
        upper Limit
        26.76
        value
        18.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Asian
  3. categories
    1. measurements
      1. comment
        Lower and upper confidence bounds cannot be estimated because the analysis includes only one subject.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        2.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Native Hawaiian or Other Pacific Islander
  4. categories
    1. measurements
      1. comment
        Upper confidence bound could not be estimated because the upper confidence limit for survival did not cross 50%
        group Id
        OG000
        lower Limit
        3.55
        upper Limit
        NA
        value
        7.35
      2. group Id
        OG001
        lower Limit
        10.94
        upper Limit
        29.76
        value
        20.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Black or African American
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.32
        upper Limit
        14.70
        value
        12.03
      2. group Id
        OG001
        lower Limit
        11.21
        upper Limit
        20.28
        value
        14.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        59
      units
      Participants
    title
    White
  6. categories
    1. measurements
      1. comment
        Upper confidence bound could not be estimated because the upper confidence limit for survival did not cross 50%
        group Id
        OG000
        lower Limit
        13.08
        upper Limit
        NA
        value
        22.88
      2. group Id
        OG001
        lower Limit
        5.34
        upper Limit
        39.22
        value
        11.94
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        4
      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 race.
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 Race
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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Preserved source evidence · Not medical advice