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NCT00542490 · REGISTRY CONDITION SEARCH

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2020-08-21

The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Progression-free Survival at 2 Years

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outcome · POSTED

Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * All patients must have undergone specified complete surgical staging. * Patients must be surgically staged endometrial cancer patients at high-risk for recurrence. * Patients must have adequate bone marrow, renal and hepatic function. Exclusion Criteria: * Patients with recurrent disease. * Patients with GOG performance status of 3 or 4.
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Radiation: Vaginal Cuff Brachytherapy
    label
    Vaginal Cuff Brachytherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Vaginal Cuff Brachytherapy
    description
    Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
    name
    Vaginal Cuff Brachytherapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
23
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Number of Patients With Progression-free Survival at 2 Years
    time Frame
    2 years
secondary Outcomes
  1. measure
    Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
    time Frame
    2 years
Full study description
brief Summary
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
detailed Description
All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c55da3c0e619e892b946
      requested nct id
      NCT00542490
      primary nct id
      NCT00542490
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
      payload sha256
      31ba5333093b2dae229a7c8f9fee0a75f3cbe085b45150ec4ddf35a02c4ac9ee
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-c55da3c0e619e892b946
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00542490
      occurrences
      1. context exact
        NCT00542490
        end
        11
        exact text
        NCT00542490
        start
        0
      offset unit
      unicode_code_points
      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
      source file sha256
      b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
      source json pointer
      /studies/3/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      bcfccf4fde11f0d930ac131bf462e2f938d54809eeef33e5926495048236bc94

    Preserved source evidence · Not medical advice