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← XELODA: locally advanced Rectal cancer

NCT04066894 · STUDY IN CONTEXT

Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study

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

SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)

No data was collected

→

secondary · POSTED

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

No data was collected

→

secondary · POSTED

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

No data was collected

→

secondary · POSTED

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

No data was collected

→

secondary · POSTED

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

No data was collected

→

secondary · POSTED

Will be reported descriptively with graphs or tabulations for categorical survey outcomes.

No data was collected

→

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 · Fecal Incontinence Quality of Life Questionnaire Summary

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-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04066894
qol key
qol-0002
source section id
NCT04066894-om-0002
source outcome index
2
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Fecal Incontinence Quality of Life Questionnaire Summary
measure definition
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No data was collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)

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-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04066894
qol key
qol-0003
source section id
NCT04066894-om-0003
source outcome index
3
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
measure definition
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No data was collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29

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-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04066894
qol key
qol-0010
source section id
NCT04066894-om-0010
source outcome index
10
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29
measure definition
Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
time frame
Up to 3 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
No data was collected
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-rectal-cancer-xeloda-40fbbc7c
nct id
NCT04066894
trial label
Sacral Nerve Stimulation in Treating Low Anterior Resection Syndrome or Fecal Incontinence in Patients With Locally Advanced Rectal Cancer or Other Pelvic Cancer, the RESTORE Study
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
1
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0000
    source section id
    NCT04066894-om-0000
    source outcome index
    0
    endpoint
    Sacral Nerve Stimulation (SNS) Success
    endpoint definition
    SNS success will be measured as a patient having the battery implanted at visit 3. Patients who do not have the SNS placed, for any reason other than insurance coverage issues, will count as not having a success. Fecal incontinence will be measured by the physician as the total number of gas, mucus, liquid stool, and solid stool accidental leakage events reported in the bowel diaries. Improvement will be determined by the physician based on bowel diary comparisons recorded before SNS lead placement at visit 1 to after lead placement at visit 2. The proportion of patients who experience SNS success will be reported with a 90% credible interval using a beta (1,1)
    time origin
    Up to visit 3
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0001
    source section id
    NCT04066894-om-0001
    source outcome index
    1
    endpoint
    Fecal Incontinence Severity Index Questionnaire Summary
    endpoint definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0002
    source section id
    NCT04066894-om-0002
    source outcome index
    2
    endpoint
    Fecal Incontinence Quality of Life Questionnaire Summary
    endpoint definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0003
    source section id
    NCT04066894-om-0003
    source outcome index
    3
    endpoint
    Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
    endpoint definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0004
    source section id
    NCT04066894-om-0004
    source outcome index
    4
    endpoint
    International Consultation on Incontinence Society - Female Lower Urinary Tract Symptoms
    endpoint definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0005
    source section id
    NCT04066894-om-0005
    source outcome index
    5
    endpoint
    Memorial Sloan Kettering Cancer Center Bowel Function Questionnaire (BFQ)
    endpoint definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time origin
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data was collected
    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
    NCT04066894
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Experimental: Sacral Nerve Stimulation (SNS)
    regimen
    Patients undergo scheduled, elective surgery for placement of the sacral nerve stimulator with external battery pack. After 2 weeks, patients undergo implantation of a subcutaneous internal battery or removal of the leads if the sacral nerve stimulator is working but does not improve symptoms. If the sacral nerve stimulator is not working, it is repositioned and patients return 2 weeks later for implantation of external battery or removal of leads.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04066894-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    harm key
    EG000
    source section id
    NCT04066894-ae
    event group key
    EG000
    event group label
    Experimental: Sacral Nerve Stimulation (SNS)
    serious affected
    0
    serious at risk
    3
    other affected
    0
    other at risk
    3
    frequency threshold
    0
    collection period
    From visit 1, up to 3 years
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-rectal-cancer-xeloda-40fbbc7c
    nct id
    NCT04066894
    qol key
    qol-0002
    source section id
    NCT04066894-om-0002
    source outcome index
    2
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Fecal Incontinence Quality of Life Questionnaire Summary
    measure definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    No data was collected
    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
    NCT04066894
    qol key
    qol-0003
    source section id
    NCT04066894-om-0003
    source outcome index
    3
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Euroqol-5 Dimensions-5 Levels (EQ-5D-5L)
    measure definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    No data was collected
    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
    NCT04066894
    qol key
    qol-0010
    source section id
    NCT04066894-om-0010
    source outcome index
    10
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Colorectal 29
    measure definition
    Will be reported descriptively with graphs or tabulations for categorical survey outcomes.
    time frame
    Up to 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    No data was collected
    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