Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02511522 · OUTCOME

Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort

Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases · Source last updated 2024-10-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
30 days

What was measured

• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.

Analysis population: All patients who completed both baseline and day 30 assessments

Groups in this outcome

Radiotherapy Combined With Best Supportive Care

Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.

Best Supportive Care Alone

Patients receive only the best supportive care.

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

Analysis denominator · Participants

GroupSource count
Radiotherapy Combined With Best Supportive Care24
Best Supportive Care Alone18

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radiotherapy Combined With Best Supportive Care16Not reportedNot reportedNot reportedNot reported
Best Supportive Care Alone4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Comment
    Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Comment
    Adjusting for stratification factor (Hepatocellular carcinoma versus liver metastases)
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      18
    units
    Participants
description
• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.
groups
  1. description
    Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.
    id
    OG000
    title
    Radiotherapy Combined With Best Supportive Care
  2. description
    Patients receive only the best supportive care.
    id
    OG001
    title
    Best Supportive Care Alone
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients who completed both baseline and day 30 assessments
reporting Status
POSTED
time Frame
30 days
title
Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice