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NCT00052910 · OUTCOME

Disease Free Survival

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer · Source last updated 2020-05-07

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

Measure
MEDIAN
Unit
years
Interval / dispersion
95% Confidence Interval
Time frame
From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years

What was measured

Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.

Groups in this outcome

Arm I (5-FU/LV)

Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.

Arm II (ECF)

Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.

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

Analysis denominator · Participants

GroupSource count
Arm I (5-FU/LV)280
Arm II (ECF)266

Reported measurements

Source class 1
Values in years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (5-FU/LV)2.7Not reported1.93.8Not reported
Arm II (ECF)2.3Not reported1.53.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Adjusted Hazard Ratio, ECF vs 5-FU/LV
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Cox Proportional Hazard
    param Value
    1.03
Complete source fields
analyses
  1. ci Lower Limit
    0.83
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.28
    estimate Comment
    Adjusted Hazard Ratio, ECF vs 5-FU/LV
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Cox Proportional Hazard
    param Value
    1.03
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        3.8
        value
        2.7
      2. group Id
        OG001
        lower Limit
        1.5
        upper Limit
        3.1
        value
        2.3
denoms
  1. counts
    1. group Id
      OG000
      value
      280
    2. group Id
      OG001
      value
      266
    units
    Participants
description
Disease free survival is defined as the time from the date of study enrollment to death or documented second primary tumor, or cancer recurrence.The distribution of disease free survival time will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
    id
    OG000
    title
    Arm I (5-FU/LV)
  2. description
    Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
    id
    OG001
    title
    Arm II (ECF)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the date of study enrollment until death or documented second primary tumor, or cancer recurrence; up to 4 years
title
Disease Free Survival
type
SECONDARY
unit Of Measure
years

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

Preserved source evidence · Not medical advice