Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00499616 · OUTCOME

Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06

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

Measure
NUMBER
Unit
percentage of 3 yr EFS rate
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years

What was measured

Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age.

Analysis population: Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.

Groups in this outcome

Group 3 (Chemotherapy, Surgery)

4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)

8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.

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

Analysis denominator · Participants

GroupSource count
Group 3 (Chemotherapy, Surgery)0
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)9

Reported measurements

Source class 1
Values in percentage of 3 yr EFS rate · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)66.7Not reported35.997.5Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    .3212
    param Type
    Log Rank Test Statistic
    param Value
    .9841
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Description
    The event-free survival distributions of patients between 12-18 months of age with Stage 4 neuroblastoma and favorable biological features on ANBL0531 and patients less than 12 months of age with Stage 4 neuroblastoma on A3961 were compared using the log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    .3212
    param Type
    Log Rank Test Statistic
    param Value
    .9841
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        35.9
        upper Limit
        97.5
        value
        66.7
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Addressed by the interim stopping rule and the comparison, by INSS stage, to the historical EFS rate of the analogous cohort of patients \< 1 yrs of age.
dispersion Type
95% Confidence Interval
groups
  1. description
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    OG000
    title
    Group 3 (Chemotherapy, Surgery)
  2. description
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S (not including liver metastases) disease who achieve a very good PR (VGPR) to chemo proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    OG001
    title
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
param Type
NUMBER
population Description
Eligible and evaluable patients with Stage 4 neuroblastoma, 12-18 months of age, and favorable biological features.
reporting Status
POSTED
time Frame
Up to 3 years
title
Comparison Between Reduce Intensity of Therapy for Patients With Stage 4 Neuroblastoma and Favorable Biological Features and Patients < 1 Year of Age With Stage 4 Neuroblastoma Treated on COG-A3961
type
PRIMARY
unit Of Measure
percentage of 3 yr EFS rate

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

Preserved source evidence · Not medical advice