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← XELODA: locally advanced Rectal cancer

NCT02966509 · STUDY IN CONTEXT

Engagement of Patients With Advanced Cancer

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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

Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.

Source null

→

secondary · POSTED

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Source null

→

secondary · POSTED

Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Source null

→

secondary · POSTED

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Source null

→

secondary · POSTED

Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.

Source null

→

secondary · POSTED

Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.

Source null

→

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-rectal-cancer-xeloda-40fbbc7c
nct id
NCT02966509
trial label
Engagement of Patients With Advanced Cancer
applicability
unclear
applicability note
Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0000
    source section id
    NCT02966509-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.
    endpoint definition
    Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.
    time origin
    6 months after each patient enrollment
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0001
    source section id
    NCT02966509-om-0001
    source outcome index
    1
    endpoint
    Emergency Department Visit (Chart Review)
    endpoint definition
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    time origin
    6 months after patient enrollment
    analysis role
    secondary
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0002
    source section id
    NCT02966509-om-0002
    source outcome index
    2
    endpoint
    Emergency Department Visit (Chart Review)
    endpoint definition
    Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    time origin
    15 months after patient enrollment
    analysis role
    secondary
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0003
    source section id
    NCT02966509-om-0003
    source outcome index
    3
    endpoint
    Hospitalization Visits (Chart Review)
    endpoint definition
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    time origin
    6 months after patient enrollment
    analysis role
    secondary
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0004
    source section id
    NCT02966509-om-0004
    source outcome index
    4
    endpoint
    Hospitalization Visits (Chart Review)
    endpoint definition
    Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.
    time origin
    15 months after patient enrollment
    analysis role
    secondary
    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-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0005
    source section id
    NCT02966509-om-0005
    source outcome index
    5
    endpoint
    Hospice Referral (Chart Review)
    endpoint definition
    Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.
    time origin
    6 months after patient enrollment
    analysis role
    secondary
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0000
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0000
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0001
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0001
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0002
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0002
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0003
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0003
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0004
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0004
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0005
    arm key
    OG000
    arm label
    A: Intervention Arm
    regimen
    All participants randomized to Arm A will receive the EPAC intervention as well as usual oncologic care. EPAC: Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
    analyzed count
    105
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    outcome key
    om-0005
    arm key
    OG001
    arm label
    B: Control Group Arm
    regimen
    All participants randomized to Arm B will receive usual oncologic care.
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02966509-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    harm key
    EG000
    source section id
    NCT02966509-ae
    event group key
    EG000
    event group label
    A: Intervention Arm
    serious affected
    0
    serious at risk
    105
    other affected
    0
    other at risk
    105
    frequency threshold
    0
    collection period
    Time frame for adverse event reporting was at 3, 6, 12, and 15 months
    event definition
    Source null
    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-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT02966509
    harm key
    EG001
    source section id
    NCT02966509-ae
    event group key
    EG001
    event group label
    B: Control Group Arm
    serious affected
    0
    serious at risk
    108
    other affected
    0
    other at risk
    108
    frequency threshold
    0
    collection period
    Time frame for adverse event reporting was at 3, 6, 12, and 15 months
    event definition
    Source null
    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