Skip to content
Triangle logo TriangleGet started
← Stage IVC Lip and Oral Cavity Cancer AJCC v8

NCT04541355 · STUDY IN CONTEXT

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

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 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

Evaluated as the successful completion of at least 5 weekly cisplatin or 2 high dose cisplatin without any extended treatment related delays more than 7 days. Overall successful completion is defined as completion by at least 75% of patients.

Source null

→

secondary · POSTED

The proportion of participants with a reported change of grade \>= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported.

Source null

→

secondary · POSTED

The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.

Source null

→

secondary · POSTED

The percentage of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms.

Source null

→

secondary · POSTED

The Hearing Handicap Inventory for Adults -Screener (HHIA-S), is a 10-item, self-assessment screening assessment developed to quickly determine the suggested level of hearing handicap. The participants respond to each of the items with a Yes (score of 4), Sometimes (score of 2), or No (score of 0). Total Scores are then summed for overall score (range 0-40) and then assigned a category for a suggested hearing handicap; 0-8 suggesting no handicap, 10-24 suggesting a mild-moderate handicap, and 26-40 suggesting significant hearing handicap. The frequency of participants for worse reported score will be reported

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

PRO-CTCAE · Number of Participants Reporting Tinnitus by Severity

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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
nct id
NCT04541355
qol key
qol-0002
source section id
NCT04541355-om-0002
source outcome index
2
instrument
PRO-CTCAE
instrument basis
matched 'pro-ctcae' in the study's own wording
scale title
Number of Participants Reporting Tinnitus by Severity
measure definition
The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
time frame
Up to 18 weeks
analysis role
secondary
reporting status
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 →
PRO-CTCAE · Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology

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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
nct id
NCT04541355
qol key
qol-0003
source section id
NCT04541355-om-0003
source outcome index
3
instrument
PRO-CTCAE
instrument basis
matched 'pro-ctcae' in the study's own wording
scale title
Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology
measure definition
The percentage of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms.
time frame
Up to 18 weeks
analysis role
secondary
reporting status
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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
nct id
NCT04541355
trial label
Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
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
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
5
harms Count
1
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0000
    source section id
    NCT04541355-om-0000
    source outcome index
    0
    endpoint
    Number of Participants Who Successfully Completed Planned Treatment
    endpoint definition
    Evaluated as the successful completion of at least 5 weekly cisplatin or 2 high dose cisplatin without any extended treatment related delays more than 7 days. Overall successful completion is defined as completion by at least 75% of patients.
    time origin
    Up to 7 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0001
    source section id
    NCT04541355-om-0001
    source outcome index
    1
    endpoint
    Proportion of Participants With Reported High Grade Ototoxicity
    endpoint definition
    The proportion of participants with a reported change of grade \>= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported.
    time origin
    Up to 18 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0002
    source section id
    NCT04541355-om-0002
    source outcome index
    2
    endpoint
    Number of Participants Reporting Tinnitus by Severity
    endpoint definition
    The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
    time origin
    Up to 18 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0003
    source section id
    NCT04541355-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology
    endpoint definition
    The percentage of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms.
    time origin
    Up to 18 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0004
    source section id
    NCT04541355-om-0004
    source outcome index
    4
    endpoint
    Frequency of Hearing Handicap
    endpoint definition
    The Hearing Handicap Inventory for Adults -Screener (HHIA-S), is a 10-item, self-assessment screening assessment developed to quickly determine the suggested level of hearing handicap. The participants respond to each of the items with a Yes (score of 4), Sometimes (score of 2), or No (score of 0). Total Scores are then summed for overall score (range 0-40) and then assigned a category for a suggested hearing handicap; 0-8 suggesting no handicap, 10-24 suggesting a mild-moderate handicap, and 26-40 suggesting significant hearing handicap. The frequency of participants for worse reported score will be reported
    time origin
    Up to 18 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cisplatin, Radiotherapy, STS
    regimen
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04541355-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cisplatin, Radiotherapy, STS
    regimen
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04541355-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cisplatin, Radiotherapy, STS
    regimen
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04541355-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cisplatin, Radiotherapy, STS
    regimen
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04541355-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cisplatin, Radiotherapy, STS
    regimen
    Participants undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
    analyzed count
    16
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT04541355-om-0004#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    harm key
    EG000
    source section id
    NCT04541355-ae
    event group key
    EG000
    event group label
    Cisplatin, Radiotherapy, STS
    serious affected
    1
    serious at risk
    16
    other affected
    16
    other at risk
    16
    frequency threshold
    0
    collection period
    Up to 18 weeks
    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-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    qol key
    qol-0002
    source section id
    NCT04541355-om-0002
    source outcome index
    2
    instrument
    PRO-CTCAE
    instrument basis
    matched 'pro-ctcae' in the study's own wording
    scale title
    Number of Participants Reporting Tinnitus by Severity
    measure definition
    The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
    time frame
    Up to 18 weeks
    analysis role
    secondary
    reporting status
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-stage-ivc-lip-and-oral-cavity-cancer-ajcc-v8
    nct id
    NCT04541355
    qol key
    qol-0003
    source section id
    NCT04541355-om-0003
    source outcome index
    3
    instrument
    PRO-CTCAE
    instrument basis
    matched 'pro-ctcae' in the study's own wording
    scale title
    Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology
    measure definition
    The percentage of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms.
    time frame
    Up to 18 weeks
    analysis role
    secondary
    reporting status
    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