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NCT00530088 · OUTCOME

Response

Photodynamic Therapy Using Porfimer Sodium in Treating Patients With Recurrent Mouth or Throat Dysplasia or Recurrent In Situ Cancer or Stage I Cancer of the Mouth or Throat · Source last updated 2014-07-04

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
2 years

What was measured

Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.

Analysis population: All treated and eligible patients

Groups in this outcome

Porfimer Sodium

Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV

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

Analysis denominator · Participants

GroupSource count
Porfimer Sodium29

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Porfimer Sodium3.5Not reported010Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        10
        value
        3.5
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
Response Rate 9.0 TUMOR RESPONSE 9.1 Tumor response will be evaluated at each follow-up visit. 9.2 Objective Tumor Response 9.21 Complete Response - CR1 Complete absence of visible lesion and negative biopsy. CR2 Complete absence of visible lesions without biopsy. 9.22 Partial Response. Reduction in the lesion size by 50% or more in the maximum size of the initial lesion or reduction in grade of lesion, e.g. severe -\> mild dysplasia. Patients that have any physical evidence of residual leukoplakia or erythroplasia will require biopsy. 9.23 No Response. All responses less than a Partial Response are considered as No Response. 9.24 Progressive Disease. Any increase in size of the treated lesion or an increase in grade of the treated lesion, i.e. mild to severe dysplasia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber. porfimer sodium: IV
    id
    OG000
    title
    Porfimer Sodium
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
2 years
title
Response
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice