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NCT00045630 · OUTCOME

Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium · Source last updated 2013-05-27

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
95% Confidence Interval
Time frame
up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

What was measured

Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.

Analysis population: All eligible patients who started treatment were included in the analysis

Groups in this outcome

Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery

Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery74

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery46Not reported3458Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34
        upper Limit
        58
        value
        46
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m\^2 of gemcitabine IV and 80 mg/m\^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
    id
    OG000
    title
    Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery
param Type
NUMBER
population Description
All eligible patients who started treatment were included in the analysis
reporting Status
POSTED
time Frame
up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )
title
Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice