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NCT00009737 · STUDY IN CONTEXT

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for 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.

primary · POSTED

Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).

All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.

→

secondary · POSTED

Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.

All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.

→

secondary · POSTED

Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).

All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.

→

secondary · POSTED

Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.

The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).

→

secondary · POSTED

Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.

The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.

→

secondary · POSTED

An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment

→

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

Unnamed quality-of-life measure · Mean Change From Baseline in Global Health Status at Week 25

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-colorectal-neoplasm
nct id
NCT00009737
qol key
qol-0003
source section id
NCT00009737-om-0003
source outcome index
3
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Mean Change From Baseline in Global Health Status at Week 25
measure definition
Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
time frame
Baseline (Days -7 to 1) and at Week 25
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score indicates better
population note
The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
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-colorectal-neoplasm
nct id
NCT00009737
trial label
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for 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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0000
    source section id
    NCT00009737-om-0000
    source outcome index
    0
    endpoint
    Disease-free Survival
    endpoint definition
    Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
    time origin
    Approximately 3 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0001
    source section id
    NCT00009737-om-0001
    source outcome index
    1
    endpoint
    Relapse-Free Survival
    endpoint definition
    Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.
    time origin
    Approximately 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0002
    source section id
    NCT00009737-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).
    time origin
    Approximately 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0003
    source section id
    NCT00009737-om-0003
    source outcome index
    3
    endpoint
    Mean Change From Baseline in Global Health Status at Week 25
    endpoint definition
    Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
    time origin
    Baseline (Days -7 to 1) and at Week 25
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0004
    source section id
    NCT00009737-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
    endpoint definition
    Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.
    time origin
    Up to Week 25
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0005
    source section id
    NCT00009737-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With Any Adverse Events and Serious Adverse Events
    endpoint definition
    An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
    time origin
    Up to Week 29
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment
    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-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    1004
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0000
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    983
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    1004
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0001
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    983
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    1004
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0002
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    983
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    836
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0003
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    769
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    995
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0004
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    974
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Capecitabine
    regimen
    Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
    analyzed count
    995
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    outcome key
    om-0005
    arm key
    OG001
    arm label
    5-Fluorouracil + Leucovorin
    regimen
    Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
    analyzed count
    974
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00009737-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT00009737
    harm key
    EG000
    source section id
    NCT00009737-ae
    event group key
    EG000
    event group label
    Capecitabine
    serious affected
    181
    serious at risk
    995
    other affected
    838
    other at risk
    995
    frequency threshold
    5
    collection period
    Up to Week 29
    event definition
    Adverse event is reported for safety population which consist of all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    harm key
    EG001
    source section id
    NCT00009737-ae
    event group key
    EG001
    event group label
    5-Fluorouracil + Leucovorin
    serious affected
    182
    serious at risk
    974
    other affected
    847
    other at risk
    974
    frequency threshold
    5
    collection period
    Up to Week 29
    event definition
    Adverse event is reported for safety population which consist of all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.
    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-colorectal-neoplasm
    nct id
    NCT00009737
    qol key
    qol-0003
    source section id
    NCT00009737-om-0003
    source outcome index
    3
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Mean Change From Baseline in Global Health Status at Week 25
    measure definition
    Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
    time frame
    Baseline (Days -7 to 1) and at Week 25
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score indicates better
    population note
    The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).
    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