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NCT01267240 · OUTCOME

Progression-free Survival

Capecitabine and Vorinostat in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer · Source last updated 2017-04-14

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.

What was measured

PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.

Analysis population: 16 of 25 patients were evaluable for response.

Groups in this outcome

Arm I (Capecitabine, Vorinostat)

Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO

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

Analysis denominator · Participants

GroupSource count
Arm I (Capecitabine, Vorinostat)16

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Capecitabine, Vorinostat)2.3Not reported1.23.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        3.6
        value
        2.3
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
PFS is defined as the duration of time from start of treatment to time of progression, death, or completion of the 1-year follow-up, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Vorinostat: Given PO
    id
    OG000
    title
    Arm I (Capecitabine, Vorinostat)
param Type
MEDIAN
population Description
16 of 25 patients were evaluable for response.
reporting Status
POSTED
time Frame
From time of treatment initiation to disease progression, death, or completion of the 1 year follow-up, whichever occurs first.
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice