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NCT02068157 · OUTCOME

Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1

Interstitial Photodynamic Therapy in Treating Patients With Recurrent Head and Neck Cancer · Source last updated 2017-10-11

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 months

What was measured

Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (Porfimer Sodium, Image-guided I-PDT)

Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given 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
Treatment (Porfimer Sodium, Image-guided I-PDT)3

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Porfimer Sodium, Image-guided I-PDT)33Not reported191Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        91
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive porfimer sodium IV over 3-5 minutes on day 0. Patients then undergo image-guided I-PDT on day 2. Laboratory Biomarker Analysis: Correlative studies Photodynamic Therapy: Undergo image-guided I-PDT Porfimer Sodium: Given IV
    id
    OG000
    title
    Treatment (Porfimer Sodium, Image-guided I-PDT)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
Up to 12 months
title
Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice