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← Clear Cell Adenocarcinoma

NCT03422198 · STUDY IN CONTEXT

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial 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 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

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

→

primary · NOT_POSTED

One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.

Source null

→

secondary · POSTED

The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.

Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.

→

secondary · POSTED

The amount charged to participants or their insurance in US Dollars (USD) was collected to evaluate cost of experimental versus standard of care courses of treatment. Data was collected at approximately six months after treatment.

Amount charged for procedures could not be obtained for six participants on the experimental arm.

→

secondary · NOT_POSTED

Participants will be asked to complete the National Cancer Institute (NCI) Diet History Questionnaire 3 (DHQIII) through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.

Source null

→

secondary · NOT_POSTED

Participants will be asked to complete the NCI Activities Completed over Time in 24-hours (ACT24) questionnaire through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.

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

EORTC QLQ · Change in Quality of Life From Baseline to 1 Month

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-clear-cell-adenocarcinoma
nct id
NCT03422198
qol key
qol-0000
source section id
NCT03422198-om-0000
source outcome index
0
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change in Quality of Life From Baseline to 1 Month
measure definition
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
time frame
At 1 month post treatment
analysis role
primary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating better
population note
Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48

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-clear-cell-adenocarcinoma
nct id
NCT03422198
qol key
qol-0002
source section id
NCT03422198-om-0002
source outcome index
2
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
measure definition
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
time frame
one month post-treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
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 · Cohort 2: Financial Toxicity Correlated With Quality of Life

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-clear-cell-adenocarcinoma
nct id
NCT03422198
qol key
qol-0006
source section id
NCT03422198-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Cohort 2: Financial Toxicity Correlated With Quality of Life
measure definition
Mean scores from the FACIT-COST (from Outcome Measure 2: Participant-Reported Financial Toxicity) will be correlated with mean QoL scores (from Outcome Measure 1). Additional information about the methods and measurements will be updated when results are reported for this outcome.
time frame
One month after brachytherapy
analysis role
secondary
reporting status
NOT_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-clear-cell-adenocarcinoma
nct id
NCT03422198
trial label
Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial 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
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
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0000
    source section id
    NCT03422198-om-0000
    source outcome index
    0
    endpoint
    Change in Quality of Life From Baseline to 1 Month
    endpoint definition
    The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
    time origin
    At 1 month post treatment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0001
    source section id
    NCT03422198-om-0001
    source outcome index
    1
    endpoint
    Cohort 2: Participant-Reported Financial Toxicity
    endpoint definition
    One month post-brachytherapy, participants will be given the Functional Assessment of Chronic Illness Therapy (FACIT) - COmprehensive Score for financial Toxicity (COST) (FACIT-COST) questionnaire. The score range is 0-44, with higher scores indicating better financial well-being. Mean scores will be reported.
    time origin
    One month after brachytherapy
    analysis role
    primary
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0002
    source section id
    NCT03422198-om-0002
    source outcome index
    2
    endpoint
    Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
    endpoint definition
    The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
    time origin
    one month post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0003
    source section id
    NCT03422198-om-0003
    source outcome index
    3
    endpoint
    USD Amount Charged for Procedures
    endpoint definition
    The amount charged to participants or their insurance in US Dollars (USD) was collected to evaluate cost of experimental versus standard of care courses of treatment. Data was collected at approximately six months after treatment.
    time origin
    Approximately 6 months after treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Amount charged for procedures could not be obtained for six participants on the experimental arm.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0004
    source section id
    NCT03422198-om-0004
    source outcome index
    4
    endpoint
    Cohort 2: Participant-Reported Diet
    endpoint definition
    Participants will be asked to complete the National Cancer Institute (NCI) Diet History Questionnaire 3 (DHQIII) through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.
    time origin
    One month after brachytherapy
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0005
    source section id
    NCT03422198-om-0005
    source outcome index
    5
    endpoint
    Cohort 2: Participant-Reported Activity Levels
    endpoint definition
    Participants will be asked to complete the NCI Activities Completed over Time in 24-hours (ACT24) questionnaire through the NCI website. Additional information about the questionnaire, methods, and measurements will be updated when results are reported for this outcome.
    time origin
    One month after brachytherapy
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Experimental: Short Course Vaginal Cuff Brachytherapy
    regimen
    Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
    analyzed count
    52
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Control: Standard of Care Vaginal Cuff Brachytherapy
    regimen
    Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Experimental: Short Course Vaginal Cuff Brachytherapy
    regimen
    Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
    analyzed count
    51
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Control: Standard of Care Vaginal Cuff Brachytherapy
    regimen
    Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0002#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Experimental: Short Course Vaginal Cuff Brachytherapy
    regimen
    Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
    analyzed count
    48
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Control: Standard of Care Vaginal Cuff Brachytherapy
    regimen
    Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
    analyzed count
    54
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03422198-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    harm key
    EG000
    source section id
    NCT03422198-ae
    event group key
    EG000
    event group label
    Experimental: Short Course Vaginal Cuff Brachytherapy
    serious affected
    2
    serious at risk
    54
    other affected
    46
    other at risk
    54
    frequency threshold
    0
    collection period
    12 months after start of brachytherapy
    event definition
    Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    harm key
    EG001
    source section id
    NCT03422198-ae
    event group key
    EG001
    event group label
    Control: Standard of Care Vaginal Cuff Brachytherapy
    serious affected
    2
    serious at risk
    54
    other affected
    50
    other at risk
    54
    frequency threshold
    0
    collection period
    12 months after start of brachytherapy
    event definition
    Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    qol key
    qol-0000
    source section id
    NCT03422198-om-0000
    source outcome index
    0
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change in Quality of Life From Baseline to 1 Month
    measure definition
    The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQ-30) is used to evaluate quality of life in cancer patients. The questionnaire was given before and one month following treatment. The quality of life score ranges from 0-100, with higher scores indicating better quality of life. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
    time frame
    At 1 month post treatment
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating better
    population note
    Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participant was excluded because they did not complete the baseline questionnaire. Two experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    qol key
    qol-0002
    source section id
    NCT03422198-om-0002
    source outcome index
    2
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Treatment-related Symptoms on HRQOL Using European Organization for Research and Treatment of Cancer Endometrial Cancer Module (EORTC EN24), Question 48
    measure definition
    The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial-24 (QLQ-EN24) was used to evaluate quality of life in cancer patients with endometrial cancers. The questionnaire was given before and one month following treatment. From this assessment, one question was selected as an indicator for this outcome, which measured whether participants felt less feminine as a result of their disease or treatment. The score ranges from 0-100, with higher scores indicating feeling less feminine. Baseline scores can be found in the Baseline Characteristics module. This outcome reports the average change from baseline to Month 1.
    time frame
    one month post-treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Five control arm participants were excluded from analysis because they did not complete the Month 1 questionnaire. One control arm participants was excluded because they did not complete the baseline questionnaire. Three experimental arm participants were excluded from analysis because they did not complete the Month 1 questionnaire.
    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-clear-cell-adenocarcinoma
    nct id
    NCT03422198
    qol key
    qol-0006
    source section id
    NCT03422198-om-0006
    source outcome index
    6
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Cohort 2: Financial Toxicity Correlated With Quality of Life
    measure definition
    Mean scores from the FACIT-COST (from Outcome Measure 2: Participant-Reported Financial Toxicity) will be correlated with mean QoL scores (from Outcome Measure 1). Additional information about the methods and measurements will be updated when results are reported for this outcome.
    time frame
    One month after brachytherapy
    analysis role
    secondary
    reporting status
    NOT_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