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NCT00112918 · OUTCOME

Disease-free Survival in Stage III Cancer Patients - Number of Events

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).

What was measured

A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.

Analysis population: The primary population for efficacy analyses was the intent to treat population (ITT; all randomized 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

Patients with a DFS event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FOLFOX4237Not reportedNot reportedNot reportedNot reported
FOLFOX4 + Bv280Not reportedNot reportedNot reportedNot reported
XELOX+Bv253Not reportedNot reportedNot reportedNot reported
Recurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FOLFOX4219Not reportedNot reportedNot reportedNot reported
FOLFOX4 + Bv253Not reportedNot reportedNot reportedNot reported
XELOX+Bv223Not reportedNot reportedNot reportedNot reported
New Occurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FOLFOX43Not reportedNot reportedNot reportedNot reported
FOLFOX4 + Bv8Not reportedNot reportedNot reportedNot reported
XELOX+Bv6Not reportedNot reportedNot reportedNot reported
Death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FOLFOX417Not reportedNot reportedNot reportedNot reported
FOLFOX4 + Bv21Not reportedNot reportedNot reportedNot reported
XELOX+Bv25Not reportedNot reportedNot reportedNot reported
Patients without events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
FOLFOX4718Not reportedNot reportedNot reportedNot reported
FOLFOX4 + Bv680Not reportedNot reportedNot reportedNot reported
XELOX+Bv699Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        237
      2. group Id
        OG001
        value
        280
      3. group Id
        OG002
        value
        253
    title
    Patients with a DFS event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        253
      3. group Id
        OG002
        value
        223
    title
    Recurrence
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
    title
    New Occurrence
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        25
    title
    Death
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        718
      2. group Id
        OG001
        value
        680
      3. group Id
        OG002
        value
        699
    title
    Patients without events
denoms
  1. counts
    1. group Id
      OG000
      value
      955
    2. group Id
      OG001
      value
      960
    3. group Id
      OG002
      value
      952
    units
    Participants
description
A disease-free survival (DFS) event was composed of a recurrence, a new occurrence of colorectal cancer or death due to any cause. Recurrence and new occurrence of colorectal cancer were based on tumor assessments made by the investigator. Triggering events for DFS are reported; a patient can have both recurrence and a new occurrence of colon cancer.
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
NUMBER
population Description
The primary population for efficacy analyses was the intent to treat population (ITT; all randomized patients) with stage III disease.
reporting Status
POSTED
time Frame
From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized).
title
Disease-free Survival in Stage III Cancer Patients - Number of Events
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice