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← Colon Cancer

NCT00096278 · STUDY IN CONTEXT

Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · POSTED

Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab

Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

→

exploratory · POSTED

Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test

Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

→

exploratory · POSTED

Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab

Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

→

exploratory · POSTED

As Measured by Blood Pressure and Antihypertensive Medication Hypertension

Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.

→

primary · POSTED

Where events are defined as recurrence, second primary cancer, or death from any cause

Source null

→

secondary · POSTED

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

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

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · The Risk Factors for Development of Proteinuria

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT00096278
qol key
qol-0006
source section id
NCT00096278-om-0006
source outcome index
6
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
The Risk Factors for Development of Proteinuria
measure definition
Source null
time frame
For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT00096278
trial label
Fluorouracil, Leucovorin, and Oxaliplatin With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II or Stage III Colon Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0002
    source section id
    NCT00096278-om-0002
    source outcome index
    2
    endpoint
    Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab
    endpoint definition
    Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab
    time origin
    Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0003
    source section id
    NCT00096278-om-0003
    source outcome index
    3
    endpoint
    Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test
    endpoint definition
    Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test
    time origin
    Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0004
    source section id
    NCT00096278-om-0004
    source outcome index
    4
    endpoint
    Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab
    endpoint definition
    Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab
    time origin
    Events measured regularly during chemotherapy and bevacizumab therapy
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0005
    source section id
    NCT00096278-om-0005
    source outcome index
    5
    endpoint
    As Measured by Blood Pressure and Antihypertensive Medication Hypertension
    endpoint definition
    As Measured by Blood Pressure and Antihypertensive Medication Hypertension
    time origin
    Group 2, every 3 months for one year post treatment
    analysis role
    exploratory
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Results of definitive analysis were negative. Tertiary outcomes therefore were not analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0000
    source section id
    NCT00096278-om-0000
    source outcome index
    0
    endpoint
    Disease-free Survival
    endpoint definition
    Where events are defined as recurrence, second primary cancer, or death from any cause
    time origin
    3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0001
    source section id
    NCT00096278-om-0001
    source outcome index
    1
    endpoint
    Survival
    endpoint definition
    Percentage of patients who did not experience an event where events are defined as death from any cause.
    time origin
    5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Survival analysis was done 2 years after Disease Free Survival analysis. For Arm 2 one additional patient had follow up at the later analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil
    regimen
    Oxaliplatin + Leucovorin + 5-Fluorouracil
    analyzed count
    1338
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
    regimen
    Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
    analyzed count
    1334
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (mFOLFOX6)
    regimen
    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
    analyzed count
    1338
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Bevacizumab, mFOLFOX6)
    regimen
    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
    analyzed count
    1335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Bevacizumab, mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (Bevacizumab, mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Arm I (mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Arm II (Bevacizumab, mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Arm I (mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Arm II (Bevacizumab, mFOLFOX6)
    regimen
    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
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00096278-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    harm key
    EG000
    source section id
    NCT00096278-ae
    event group key
    EG000
    event group label
    Oxaliplatin + Leucovorin + 5-Fluorouracil
    serious affected
    81
    serious at risk
    1326
    other affected
    954
    other at risk
    1326
    frequency threshold
    5
    collection period
    Source null
    event definition
    Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    harm key
    EG001
    source section id
    NCT00096278-ae
    event group key
    EG001
    event group label
    Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
    serious affected
    270
    serious at risk
    1334
    other affected
    1043
    other at risk
    1334
    frequency threshold
    5
    collection period
    Source null
    event definition
    Participants at Risk includes any patient who submitted an Adverse Event (AE) form.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00096278
    qol key
    qol-0006
    source section id
    NCT00096278-om-0006
    source outcome index
    6
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    The Risk Factors for Development of Proteinuria
    measure definition
    Source null
    time frame
    For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice