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NCT01042522 · OUTCOME

Progression-free Survival (PFS)

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors · Source last updated 2022-01-25

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.

What was measured

The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Analysis population: Intent to Treat

Groups in this outcome

Arm I (Paclitaxel, Carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV

Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)

Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies

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 I (Paclitaxel, Carboplatin)31
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)32

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Carboplatin)27.7Not reported11.241.0Not reported
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)19.7Not reported10.452.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.2
        upper Limit
        41.0
        value
        27.7
      2. group Id
        OG001
        lower Limit
        10.4
        upper Limit
        52.7
        value
        19.7
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      32
    units
    Participants
description
The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
    id
    OG000
    title
    Arm I (Paclitaxel, Carboplatin)
  2. description
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
param Type
MEDIAN
population Description
Intent to Treat
reporting Status
POSTED
time Frame
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice