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NCT00068406 · OUTCOME

Complete Clinical and Pathologic Response

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva · Source last updated 2017-11-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
90% Confidence Interval
Time frame
Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.

What was measured

Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.

Analysis population: Eligible and treated patients

Groups in this outcome

Cisplatin + Radiation, Then Surgery

Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cisplatin + Radiation, Then Surgery58

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery50Not reported3961Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39
        upper Limit
        61
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Complete clinical and pathologic response is defined as the disappearance of all gross tumor during chemoradiation with no residual tumor present in the surgical specimen.
dispersion Type
90% Confidence Interval
groups
  1. description
    Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
    id
    OG000
    title
    Cisplatin + Radiation, Then Surgery
param Type
NUMBER
population Description
Eligible and treated patients
reporting Status
POSTED
time Frame
Seven weeks after initiating treatment for clinical response and up to fifteen weeks for assessment of pathologic response.
title
Complete Clinical and Pathologic Response
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice