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NCT00589121 · OUTCOME

Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg · Source last updated 2019-06-12

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 after start of treatment (+/- 3 months)

What was measured

The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.

Analysis population: All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)

Groups in this outcome

Cohort B - No Chemotherapy

Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost

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

Analysis denominator · Participants

GroupSource count
Cohort B - No Chemotherapy57

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort B - No Chemotherapy10.5Not reported2.618.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.
    group Ids
    1. OG000
    non Inferiority Comment
    The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0005
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Initially designed to test for a 20% absolute improvement from 37% (fixed rate) to 17% using Fisher's exact test, requiring 41 patients per cohort (51 with 20% ineligibility) with 5% type I error and 90% statistical power. During accrual, the sample size for cohort B was increased to 66 (83 with 20% ineligibility) to test for a 15% improvement with 5% type I error and 85% power.
    group Ids
    1. OG000
    non Inferiority Comment
    The fixed rate of 37% comes from the published National Cancer Institute of Canada trial SR2 (CAN-NCIC-SR2: Phase III Randomized Study of Pre- vs Postoperative Radiotherapy in Curable Extremity Soft Tissue Sarcoma) receiving preoperative radiation therapy without image-guided radiation therapy (IGRT).
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0005
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.6
        upper Limit
        18.5
        value
        10.5
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
The rate of patients with late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC(European Organisation for Research and Treatment of Cancer)/RTOG (Radiation Therapy Oncology Group) criteria. Grade refers to the severity of the morbidity. The RTOG/EORTC Late Radiation Morbidity Scoring Schema assigns Grades 1 through 5 with unique clinical descriptions of severity for each morbidity based on this general guideline: Grade 1 Mild , Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to morbidity.
dispersion Type
95% Confidence Interval
groups
  1. description
    Radiation therapy followed by surgery followed by, for patients with positive margins, radiation therapy boost
    id
    OG000
    title
    Cohort B - No Chemotherapy
param Type
NUMBER
population Description
All eligible patients on Cohort B who started study treatment and had an assessment of toxicity at 2 years. (See limitations and caveats, Cohort A is not included.)
reporting Status
POSTED
time Frame
2 years after start of treatment (+/- 3 months)
title
Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness) at 2 Years From the Start of Radiotherapy as Measured by EORTC/RTOG Criteria
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice