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NCT00554788 · OUTCOME

Event-free Survival (EFS)

Combination Chemotherapy, Autologous Stem Cell Transplant, and/or Radiation Therapy in Treating Young Patients With Extraocular Retinoblastoma · Source last updated 2025-01-13

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

Measure
NUMBER
Unit
Probability
Interval / dispersion
95% Confidence Interval
Time frame
At 1 year

What was measured

The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.

Analysis population: Ineligible patients were excluded from analysis

Groups in this outcome

Stage 2/3 Patients

Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).

Stage 4a Patients

Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

Stage 4b Patients

Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.

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

Analysis denominator · Participants

GroupSource count
Stage 2/3 Patients19
Stage 4a Patients18
Stage 4b Patients20

Reported measurements

Source class 1
Values in Probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stage 2/3 Patients88Not reported6097Not reported
Stage 4a Patients83Not reported5594Not reported
Stage 4b Patients28Not reported1049Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        60
        upper Limit
        97
        value
        88
      2. group Id
        OG001
        lower Limit
        55
        upper Limit
        94
        value
        83
      3. group Id
        OG002
        lower Limit
        10
        upper Limit
        49
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      20
    units
    Participants
description
The probability of surviving patients who did not experience events at 1 year following enrollment. An event is defined as relapse, second malignancy, or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with orbital disease (including microscopic trans-scleral invasion seen on enucleation pathology), optic nerve margin (+), and/or regional nodal disease, but no other sites of metastases. Stage 2 and 3 patients will receive Induction chemotherapy and External Beam Radiation Therapy, but will not receive Consolidation therapy (High-Dose Chemotherapy with Stem Cell Rescue).
    id
    OG000
    title
    Stage 2/3 Patients
  2. description
    Patients with overt distant metastatic disease (such as bone, bone marrow, and/or liver) but no detectable CNS involvement. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    OG001
    title
    Stage 4a Patients
  3. description
    Patients with overt CNS involvement (brain parenchyma, leptomeninges and CSF cytology). Patients with trilateral retinoblastoma will be included. Patients will receive Induction chemotherapy, Stem Cell Harvesting, Consolidation with Stem Cell Rescue, and depending on response to Induction chemotherapy, possibly External Beam Radiation Therapy.
    id
    OG002
    title
    Stage 4b Patients
param Type
NUMBER
population Description
Ineligible patients were excluded from analysis
reporting Status
POSTED
time Frame
At 1 year
title
Event-free Survival (EFS)
type
PRIMARY
unit Of Measure
Probability

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

Preserved source evidence · Not medical advice