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NCT01611662 · OUTCOME

Pathological Complete Response Rate Following Chemotherapy Before Surgery

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer · Source last updated 2019-07-29

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 5 years

What was measured

Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy

Groups in this outcome

Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)

Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)31

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)32Not reported1648Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16
        upper Limit
        48
        value
        32
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy. gemcitabine hydrochloride: Given IV cisplatin: Given IV therapeutic conventional surgery: Undergo radical cystectomy laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 5 years
title
Pathological Complete Response Rate Following Chemotherapy Before Surgery
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice