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NCT00096278 · OUTCOME

Survival

Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer · Source last updated 2019-07-30

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
Not reported
Time frame
5 years

What was measured

Percentage of patients who did not experience an event where events are defined as death from any cause.

Analysis population: Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.

Groups in this outcome

Arm I (mFOLFOX6)

Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV

Arm II (Bevacizumab, mFOLFOX6)

Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV bevacizumab: Given IV

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 (mFOLFOX6)1338
Arm II (Bevacizumab, mFOLFOX6)1335

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (mFOLFOX6)77.6Not reportedNot reportedNot reportedNot reported
Arm II (Bevacizumab, mFOLFOX6)78.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        77.6
      2. group Id
        OG001
        value
        78.7
denoms
  1. counts
    1. group Id
      OG000
      value
      1338
    2. group Id
      OG001
      value
      1335
    units
    Participants
description
Percentage of patients who did not experience an event where events are defined as death from any cause.
groups
  1. description
    Patients receive adjuvant chemotherapy comprising concurrent oxaliplatin and leucovorin calcium IV over 2 hours on day 1. Patients also receive adjuvant fluorouracil IV over 2-4 minutes on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV
    id
    OG000
    title
    Arm I (mFOLFOX6)
  2. description
    Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive adjuvant oxaliplatin, leucovorin calcium, and fluorouracil as in arm I. Treatment repeats every 14 days for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of adjuvant chemotherapy, patients continue to receive bevacizumab alone every 14 days for 6 months in the absence of disease progression or unacceptable toxicity. oxaliplatin: Given IV leucovorin calcium: Given IV fluorouracil: Given IV bevacizumab: Given IV
    id
    OG001
    title
    Arm II (Bevacizumab, mFOLFOX6)
param Type
NUMBER
population Description
Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.
reporting Status
POSTED
time Frame
5 years
title
Survival
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice