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NCT00593840 · STUDY IN CONTEXT

Phase II Trial Evaluating Elimination of Radiation Therapy

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. 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

* Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.

Source null

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secondary · POSTED

* Recurrence is defined as the return of cancer after treatment * Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame

Source null

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secondary · POSTED

-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.

65 out of 73 patients had evaluable QOL data in Arm 1.

→

secondary · POSTED

-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.

Source null

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secondary · NOT_POSTED

Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms

Source null

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secondary · NOT_POSTED

Disease Specific Survival Rate

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

Unnamed quality-of-life measure · Quality of Life (QOL) as Measured by Overall Global QOL Scores

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-laryngeal-cancer
nct id
NCT00593840
qol key
qol-0002
source section id
NCT00593840-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
Quality of Life (QOL) as Measured by Overall Global QOL Scores
measure definition
-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
time frame
Median follow-up was 22 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
65 out of 73 patients had evaluable QOL data in Arm 1.
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 · Quality of Life (QOL) as Measured by Xerostomia QOL Data

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-laryngeal-cancer
nct id
NCT00593840
qol key
qol-0003
source section id
NCT00593840-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
Quality of Life (QOL) as Measured by Xerostomia QOL Data
measure definition
-The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
time frame
Median follow-up was 22 months
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-laryngeal-cancer
nct id
NCT00593840
trial label
Phase II Trial Evaluating Elimination of Radiation Therapy
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.
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
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0000
    source section id
    NCT00593840-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With a Recurrence in the Unirradiated Neck(s)
    endpoint definition
    * Recurrence in a PN0 neck that was not treated is the critical endpoint in this study. * Recurrence is defined as the return of cancer after treatment * Recurrence is determined by a CT, PET/CT, or MRI and it will be fused with the original treatment planning CT scan. This will allow correlation between the original dose distribution and contours with any recurrent disease.
    time origin
    12 months of follow-up
    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-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0001
    source section id
    NCT00593840-om-0001
    source outcome index
    1
    endpoint
    Kaplan Meier Estimate of Locoregional Recurrence Free Survival
    endpoint definition
    * Recurrence is defined as the return of cancer after treatment * Kaplan Meier Estimate of the percentage of participants whose cancer has not returned locoregionally in the specified time frame
    time origin
    3 years
    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-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0002
    source section id
    NCT00593840-om-0002
    source outcome index
    2
    endpoint
    Quality of Life (QOL) as Measured by Overall Global QOL Scores
    endpoint definition
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
    time origin
    Median follow-up was 22 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    65 out of 73 patients had evaluable QOL data in Arm 1.
    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-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0003
    source section id
    NCT00593840-om-0003
    source outcome index
    3
    endpoint
    Quality of Life (QOL) as Measured by Xerostomia QOL Data
    endpoint definition
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
    time origin
    Median follow-up was 22 months
    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-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0004
    source section id
    NCT00593840-om-0004
    source outcome index
    4
    endpoint
    Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms
    endpoint definition
    Compare Standard Treatment Volume (CTV and PTV) With Protocol Defined Treatment Volume in Terms of Organ Specific Dose Volume Histograms
    time origin
    Completion of follow-up (minimum of 5 years from completion of treatment)
    analysis role
    secondary
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0005
    source section id
    NCT00593840-om-0005
    source outcome index
    5
    endpoint
    Disease Specific Survival Rate
    endpoint definition
    Disease Specific Survival Rate
    time origin
    Completion of follow-up (minimum of 5 years from completion of treatment)
    analysis role
    secondary
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm 1: IMRT
    regimen
    CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00593840-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm 1: IMRT
    regimen
    CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions
    analyzed count
    34
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00593840-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm 1: IMRT
    regimen
    CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00593840-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm 1: IMRT
    regimen
    CTV1 = 66 Gy in 33 fractions CTV2 = 60 Gy in 33 fractions CTV3 = 56 Gy in 33 fractions CTV3 Proto = 56 Gy in 33 fractions
    analyzed count
    65
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00593840-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-laryngeal-cancer
    nct id
    NCT00593840
    harm key
    EG000
    source section id
    NCT00593840-ae
    event group key
    EG000
    event group label
    Arm 1: Intensity Modulated Radiation Therapy (IMRT)
    serious affected
    7
    serious at risk
    72
    other affected
    72
    other at risk
    72
    frequency threshold
    0
    collection period
    Source null
    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-laryngeal-cancer
    nct id
    NCT00593840
    qol key
    qol-0002
    source section id
    NCT00593840-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
    Quality of Life (QOL) as Measured by Overall Global QOL Scores
    measure definition
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Global score was scaled for a total score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
    time frame
    Median follow-up was 22 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    65 out of 73 patients had evaluable QOL data in Arm 1.
    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-laryngeal-cancer
    nct id
    NCT00593840
    qol key
    qol-0003
    source section id
    NCT00593840-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
    Quality of Life (QOL) as Measured by Xerostomia QOL Data
    measure definition
    -The Quality of Life (QOL) Evaluation (Swallowing and Dryness Questionnaire) will be used. 20 questions with answers of Strongly Agree to Strongly Disagree. Xerostomia score was scaled for a total xerostomia score from 0 to 100 with 0 being the worst QOL and 100 the best QOL.
    time frame
    Median follow-up was 22 months
    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