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NCT00789958 · OUTCOME

2-year Stratum-specific Local Relapse Rate

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct · Source last updated 2018-04-09

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years from registration

What was measured

Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).

Analysis population: Eligible and analyzable patients that received protocol treatment.

Groups in this outcome

Patients With Negative Margins of Resection (R0)

Eligible and analyzable patients that received a resection with negative (R0) margins.

Patients w/Microscopically Positive Margin of Resection (R1)

Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.

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

Analysis denominator · Participants

GroupSource count
Patients With Negative Margins of Resection (R0)54
Patients w/Microscopically Positive Margin of Resection (R1)25

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patients With Negative Margins of Resection (R0)9Not reported217Not reported
Patients w/Microscopically Positive Margin of Resection (R1)16Not reported230Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        17
        value
        9
      2. group Id
        OG001
        lower Limit
        2
        upper Limit
        30
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Local relapse is any evidence of new disease within the primary tumor bed or the regional (retroperitoneal, celiac, and portal vein nodes) lymphatics (these areas are to be encompassed within the radiation fields).
dispersion Type
95% Confidence Interval
groups
  1. description
    Eligible and analyzable patients that received a resection with negative (R0) margins.
    id
    OG000
    title
    Patients With Negative Margins of Resection (R0)
  2. description
    Eligible and analyzable patients that received a resection with microscopically positive (R1) margins.
    id
    OG001
    title
    Patients w/Microscopically Positive Margin of Resection (R1)
param Type
NUMBER
population Description
Eligible and analyzable patients that received protocol treatment.
reporting Status
POSTED
time Frame
Up to 2 years from registration
title
2-year Stratum-specific Local Relapse Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice