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← Colon Cancer

NCT00217737 · STUDY IN CONTEXT

Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II 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 · NOT_POSTED

The association between onset of neurotoxicity and oxaliplatin exposure will be assessed. The difference in neurotoxicity rates between patients with and without a given polymorphism will be evaluated.

Source null

→

primary · POSTED

Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.

Eligible patients who were registered or randomized at Step 2 were included in this analysis.

→

secondary · POSTED

Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.

Eligible patients who were registered or randomized at Step 2 were included in this analysis.

→

secondary · POSTED

Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The following patient/tumor characteristics were associated with overall survival: * ECOG Performance Status (0, 1, or 2) * Age * Sex (male, female) * Primary tumor site (right-side colon, transverse colon, left-side colon, or other) * Number of regional lymph nodes Hazard ratios with adjustment for other covariates are reported with OS as the outcome variable.

Eligible patients who had advanced to step 2 (Arms A, B and C) and had complete data on patient/tumor characteristics are included.

→

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

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT00217737
trial label
Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II 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
4
harms Count
4
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0003
    source section id
    NCT00217737-om-0003
    source outcome index
    3
    endpoint
    The Association Between Oxaliplatin Exposure, Allelic Variants in Candidate Genes, and Neurotoxicity
    endpoint definition
    The association between onset of neurotoxicity and oxaliplatin exposure will be assessed. The difference in neurotoxicity rates between patients with and without a given polymorphism will be evaluated.
    time origin
    Assessed at baseline, every 2 weeks while on treatment, up to 10 years
    analysis role
    exploratory
    reporting status
    NOT_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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0000
    source section id
    NCT00217737-om-0000
    source outcome index
    0
    endpoint
    Disease-free Survival Rate at 5 Years
    endpoint definition
    Disease-free survival (DFS) is defined as the time from randomization to the earlier of disease recurrence, new invasive primary cancer, or death from any cause. The Kaplan-Meier estimates were used to characterize the 5-year DFS rates.
    time origin
    Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who were registered or randomized at Step 2 were included in this analysis.
    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
    NCT00217737
    outcome key
    om-0001
    source section id
    NCT00217737-om-0001
    source outcome index
    1
    endpoint
    Overall Survival Rate at 5 Years
    endpoint definition
    Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The Kaplan-Meier estimates were used to characterize the 5-year OS rates.
    time origin
    Assessed every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who were registered or randomized at Step 2 were included in this analysis.
    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
    NCT00217737
    outcome key
    om-0002
    source section id
    NCT00217737-om-0002
    source outcome index
    2
    endpoint
    The Impact of Tumor Biological Characteristics on Overall Survival
    endpoint definition
    Overall survival (OS) is defined as the time from randomization to death from any cause. OS is censored at the date of last contact for patients still alive. The following patient/tumor characteristics were associated with overall survival: * ECOG Performance Status (0, 1, or 2) * Age * Sex (male, female) * Primary tumor site (right-side colon, transverse colon, left-side colon, or other) * Number of regional lymph nodes Hazard ratios with adjustment for other covariates are reported with OS as the outcome variable.
    time origin
    Assessed at baseline, every 3 months for patients within 2 years of step 2 randomization, every 6 months during 3-5 years from step 2 randomization, and then every 12 months until 10 years from step 2 randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible patients who had advanced to step 2 (Arms A, B and C) and had complete data on patient/tumor characteristics are included.
    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
    NCT00217737
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm A (5-FU, Leucovorin, Oxaliplatin)
    regimen
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    424
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
    regimen
    Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    435
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm C (Observation)
    regimen
    Patients undergo observation.
    analyzed count
    998
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm A (5-FU, Leucovorin, Oxaliplatin)
    regimen
    Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1. Patients also receive fluorouracil IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    424
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
    regimen
    Patients receive oxaliplatin, leucovorin calcium, and fluorouracil as in Arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone for 12 additional courses in the absence of disease progression or unacceptable toxicity.
    analyzed count
    435
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm C (Observation)
    regimen
    Patients undergo observation.
    analyzed count
    998
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Tumor Biological Characteristics and Overall Survival Analysis
    regimen
    Eligible patients who had advanced to step 2 (Arms A, B and C) and had complete data on patient/tumor characteristics are included.
    analyzed count
    1368
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217737-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colon-cancer
    nct id
    NCT00217737
    harm key
    EG000
    source section id
    NCT00217737-ae
    event group key
    EG000
    event group label
    Arm A (5-FU, Leucovorin, Oxaliplatin)
    serious affected
    308
    serious at risk
    428
    other affected
    399
    other at risk
    428
    frequency threshold
    5
    collection period
    Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
    event definition
    All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.
    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
    NCT00217737
    harm key
    EG001
    source section id
    NCT00217737-ae
    event group key
    EG001
    event group label
    Arm B (5-FU, Leucovorin, Oxaliplatin, Bevacizumab)
    serious affected
    292
    serious at risk
    410
    other affected
    388
    other at risk
    410
    frequency threshold
    5
    collection period
    Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
    event definition
    All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.
    undenominated note
    Source null
    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
    NCT00217737
    harm key
    EG002
    source section id
    NCT00217737-ae
    event group key
    EG002
    event group label
    Arm C (Observation)
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
    event definition
    All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.
    undenominated note
    Source null
    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
    NCT00217737
    harm key
    EG003
    source section id
    NCT00217737-ae
    event group key
    EG003
    event group label
    No Randomization/Registration at Step 2
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    5
    collection period
    Assessed every 2 weeks while on treatment and for 30 days after the end of treatment, up to 10 years
    event definition
    All patients received treatment at Step 2 and had adverse event data were included in the analysis of adverse events. Patients who underwent observation in Arm C did not receive any treatment, so no adverse event data were collected for these patients. All patients registered/randomized at Step 2 were included in the analysis of all-cause mortality.
    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
    setting source links

      Preserved source evidence · Not medical advice