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NCT00112918 · OUTCOME

Overall Survival in Stage III Cancer Patients - Time to Event

Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer · Source last updated 2013-08-27

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).

What was measured

Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.

Analysis population: ITT patients with Stage III disease.

Groups in this outcome

FOLFOX4

Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.

FOLFOX4 + Bv

Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

XELOX+Bv

Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).

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

Analysis denominator · Participants

GroupSource count
FOLFOX4955
FOLFOX4 + Bv960
XELOX+Bv952

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FOLFOX4NANot reportedNANAMedian time to event and 95% confidence intervals could not be estimated due to the low number of events.
FOLFOX4 + BvNANot reportedNANAMedian time to event and 95% confidence intervals could not be estimated due to the low number of events.
XELOX+BvNANot reportedNANAMedian time to event and 95% confidence intervals could not be estimated due to the low number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Median time to event and 95% confidence intervals could not be estimated due to the low number of events.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      955
    2. group Id
      OG001
      value
      960
    3. group Id
      OG002
      value
      952
    units
    Participants
description
Overall survival was defined as the time between date of randomization and date of death due to any cause. Patients not reported as having died at the time of the analysis were censored at the date they were last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Weeks 1-24: Oxaliplatin was administered as an 85 mg/m\^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only.
    id
    OG000
    title
    FOLFOX4
  2. description
    Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m\^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m\^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m\^2 bolus injection, and then as a 600 mg/m\^2 continuous infusion over 22 hours. Leucovorin 200 mg/m\^2 (alone), followed by 5-FU 400 mg/m\^2 bolus injection, and 5-FU 600 mg/m\^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    OG001
    title
    FOLFOX4 + Bv
  3. description
    Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m\^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m\^2 twice daily (equivalent to a total daily dose of 2000 mg/m\^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks).
    id
    OG002
    title
    XELOX+Bv
param Type
MEDIAN
population Description
ITT patients with Stage III disease.
reporting Status
POSTED
time Frame
From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized).
title
Overall Survival in Stage III Cancer Patients - Time to Event
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice