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← Vulvar Cancer

NCT01399658 · STUDY IN CONTEXT

Image-Guided Gynecologic Brachytherapy

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

Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.

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-vulvar-cancer
nct id
NCT01399658
trial label
Image-Guided Gynecologic Brachytherapy
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
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT01399658
    outcome key
    om-0000
    source section id
    NCT01399658-om-0000
    source outcome index
    0
    endpoint
    Mean Doses Given
    endpoint definition
    Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
    time origin
    Measured while on treatment, up to 2 months.
    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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT01399658
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Image-Guided Brachytherapy
    regimen
    Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
    analyzed count
    84
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01399658-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT01399658
    harm key
    EG000
    source section id
    NCT01399658-ae
    event group key
    EG000
    event group label
    Image-Guided Brachytherapy
    serious affected
    0
    serious at risk
    93
    other affected
    86
    other at risk
    93
    frequency threshold
    0
    collection period
    From registration to 90 days post-procedure, up to 15 months.
    event definition
    Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
    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