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NCT00104676 · OUTCOME

Overall Survival

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors · Source last updated 2025-02-06

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
3 years from randomization

What was measured

To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.

Groups in this outcome

Arm I

Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered

Arm II

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion

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 I98
Arm II105

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I65Not reported5575Not reported
Arm II73Not reported6481Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.34
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Comment
    Adjusted on the stratification factor (treatment centers)
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.46
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.34
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Comment
    Adjusted on the stratification factor (treatment centers)
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55
        upper Limit
        75
        value
        65
      2. group Id
        OG001
        lower Limit
        64
        upper Limit
        81
        value
        73
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    2. group Id
      OG001
      value
      105
    units
    Participants
description
To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
    id
    OG000
    title
    Arm I
  2. description
    Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
    id
    OG001
    title
    Arm II
param Type
NUMBER
reporting Status
POSTED
time Frame
3 years from randomization
title
Overall Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice