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NCT01966809 · OUTCOME

Six Month Relapse-free Survival (RFS).

Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas · Source last updated 2019-08-20

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Six months from PDT

What was measured

Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.

Groups in this outcome

Photofrin Photodynamic Therapy.

Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.

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

Analysis denominator · Participants

GroupSource count
Photofrin Photodynamic Therapy.1

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Photofrin Photodynamic Therapy.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.
groups
  1. description
    Photofrin photodynamic therapy. Drug - 2.5 mg/kg, light - 240 mJ/cm2. Photofrin photodynamic therapy.: The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula: Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence.
    id
    OG000
    title
    Photofrin Photodynamic Therapy.
param Type
NUMBER
reporting Status
POSTED
time Frame
Six months from PDT
title
Six Month Relapse-free Survival (RFS).
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice