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NCT00587964 · OUTCOME

Local Control

Phase II Trial of Stereotactic Radiosurgery Boost Following Surgical Resection for Brain Metastases · Source last updated 2016-02-22

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

following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.

Groups in this outcome

Treatment - Stereotactic Radiosurgery

Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.

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 - Stereotactic Radiosurgery39

Reported measurements

Local Control
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment - Stereotactic Radiosurgery13Not reportedNot reportedNot reportedNot reported
No Evidence of Disease (NED)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment - Stereotactic Radiosurgery23Not reportedNot reportedNot reportedNot reported
Progression of Disease (POD)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment - Stereotactic Radiosurgery2Not reportedNot reportedNot reportedNot reported
Relapse/Recurrence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment - Stereotactic Radiosurgery1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Local Control
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
    title
    No Evidence of Disease (NED)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progression of Disease (POD)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Relapse/Recurrence
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
following a combination of stereotactic radiosurgery and surgical resection for brain metastases; to determine the incidence of the brain injury following the combination therapy. Local control: Absence of radiographic evidence of tumor at the site of therapy constitutes local control of the treated disease.Recurrence in the treated region: The reappearance of tumor on any MRI or CT scan at the site of treatment constitutes recurrent disease at the treated region. Recurrence outside the treated region: The development of new intracranial metastatic foci or leptomeningeal disease constitutes recurrence outside the treated region. Leptomeningeal disease will be documented by a positive CSF cytology, abnormal myelogram or spinal MRI. No evidence of disease: Absence of clinical or radiographic evidence of tumor both at the site of therapy and elsewhere in the brain constitutes no evidence of disease.
groups
  1. description
    Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
    id
    OG000
    title
    Treatment - Stereotactic Radiosurgery
param Type
NUMBER
reporting Status
POSTED
time Frame
1 year
title
Local Control
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice