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NCT00789958 · OUTCOME

2-year Disease-free Survival in All Patients

S0809: Capecitabine, Gemcitabine, and RT in Patients w/Cholangiocarcinoma of the Gallbladder or Bile Duct · Source last updated 2018-04-09

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 2 years from registration

What was measured

Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.

Analysis population: Eligible and analyzable patients that received protocol treatment.

Groups in this outcome

Adjuvant Chemotherapy + Chemoradiotherapy

Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.

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

Analysis denominator · Participants

GroupSource count
Adjuvant Chemotherapy + Chemoradiotherapy79

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adjuvant Chemotherapy + Chemoradiotherapy52Not reported4062Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40
        upper Limit
        62
        value
        52
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    units
    Participants
description
Disease-free survival is calculated from date of registration to date of first documentation of relapse or death due to any cause. Patients last known to be alive are censored at date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Adjuvant Chemotherapy: Capecitabine, 1500 mg/m\^2/day, PO, Every 12 hrs on Days 1-14 of each cycle; Gemcitabine hydrochloride, 1000 mg/m\^2, IV, Days 1 \& 8 of each cycle. Chemoradiotherapy: Capecitabine, 1330 mg/m\^2/day, PO, Every 12 hrs, 7 days per week beginning the first day of RT and finishing the last day of RT; Radiation (RT): 3-dimensional conformal radiation therapy - 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 900 cGy during week 1 in 180 cGy fractions; intensity-modulated radiation therapy: 4,500 cGy over 5 weeks (5 days/week) in 180 cGy/fraction + 5,250 cGy in 210 cGy/fraction for a total of 25 fractions.
    id
    OG000
    title
    Adjuvant Chemotherapy + Chemoradiotherapy
param Type
NUMBER
population Description
Eligible and analyzable patients that received protocol treatment.
reporting Status
POSTED
time Frame
Up to 2 years from registration
title
2-year Disease-free Survival in All Patients
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice