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NCT00346164 · OUTCOME

Probability for Event Free Survival.

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma · Source last updated 2022-04-28

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

Measure
NUMBER
Unit
Probability of EFS at 5 years
Interval / dispersion
95% Confidence Interval
Time frame
5 years

What was measured

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Analysis population: Ineligible patients are excluded as well as patients who were treated on the incorrect arm.

Groups in this outcome

Arm A: No Adjuvant Treatment

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery

Arm B: Low Risk; Adjuvant Radiotherapy

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy

Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV

Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy

High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: 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
Arm A: No Adjuvant Treatment205
Arm B: Low Risk; Adjuvant Radiotherapy17
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy110
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy196

Reported measurements

Source class 1
Values in Probability of EFS at 5 years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: No Adjuvant Treatment0.8984Not reported0.83950.9572Not reported
Arm B: Low Risk; Adjuvant Radiotherapy0.7647Not reported0.53480.9946Not reported
Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy0.6079Not reported0.48180.7341Not reported
Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy0.4873Not reported0.39510.5796Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8395
        upper Limit
        0.9572
        value
        0.8984
      2. group Id
        OG001
        lower Limit
        0.5348
        upper Limit
        0.9946
        value
        0.7647
      3. group Id
        OG002
        lower Limit
        0.4818
        upper Limit
        0.7341
        value
        0.6079
      4. group Id
        OG003
        lower Limit
        0.3951
        upper Limit
        0.5796
        value
        0.4873
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      110
    4. group Id
      OG003
      value
      196
    units
    Participants
description
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only). clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery
    id
    OG000
    title
    Arm A: No Adjuvant Treatment
  2. description
    Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy
    id
    OG001
    title
    Arm B: Low Risk; Adjuvant Radiotherapy
  3. description
    High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
    id
    OG002
    title
    Arm C: Intermediate & High Risk; Adjuvant Chemoradiotherapy
  4. description
    High risk \[metastatic, resected, incompletely resected, or unresected disease\] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13. doxorubicin hydrochloride: Given IV clinical observation: Patients undergo observation therapeutic conventional surgery: Patients undergo surgery 3-dimensional conformal radiation therapy: Patients undergo radiotherapy ifosfamide: Given IV
    id
    OG003
    title
    Arm D: Intermediate & High Risk; Neoadjuvant Chemoradiotherapy
param Type
NUMBER
population Description
Ineligible patients are excluded as well as patients who were treated on the incorrect arm.
reporting Status
POSTED
time Frame
5 years
title
Probability for Event Free Survival.
type
PRIMARY
unit Of Measure
Probability of EFS at 5 years

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

Preserved source evidence · Not medical advice