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NCT00985140 · OUTCOME

Clinical Response Rate

Phase 2 Total Skin Electron Beam Therapy (TSEBT 12 Gy) in Stage IB-IIIA Mycosis Fungoides · Source last updated 2017-06-02

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
1 year

What was measured

After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease.

Analysis population: All patients who completed treatment.

Groups in this outcome

12 Gy TSEBT

Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .

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

Analysis denominator · Participants

GroupSource count
12 Gy TSEBT13

Reported measurements

Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
12 Gy TSEBT11Not reportedNot reportedNot reportedNot reported
Stable disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
12 Gy TSEBT2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable disease
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
After the completion of TSEBT, patients will be followed every 4 weeks until 24 weeks ,and then every 8 weeks for a total of 12 months or until there is disease progression, relapse, or the initiation of a new anti-cancer therapy. The primary endpoint for the trial was the clinical response rate as defined by the modified severity weighted assessment tool (mSWAT) Partial response was defined as 50% improvement in the mSWAT. Complete response was complete disappearance of disease.
groups
  1. description
    Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional "boost" treatment not to exceed 12 Gy. .
    id
    OG000
    title
    12 Gy TSEBT
param Type
NUMBER
population Description
All patients who completed treatment.
reporting Status
POSTED
time Frame
1 year
title
Clinical Response Rate
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice