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NCT04145349 · OUTCOME

Progression Free Survival (PFS)

CAMPFIRE: A Study of Ramucirumab (LY3009806) in Children and Young Adults With Desmoplastic Small Round Cell Tumor · Source last updated 2026-08-07

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
98% Confidence Interval
Time frame
Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months)

What was measured

PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). The posterior median and 98% credible interval were estimated using Bayesian analysis. Data are presented as the posterior median with 98% credible interval.

Analysis population: All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 4, Cyclophosphamide + Vinorelbine = 2.

Groups in this outcome

Ramucirumab + Cyclophosphamide + Vinorelbine

Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

Cyclophosphamide + Vinorelbine

Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab + Cyclophosphamide + Vinorelbine20
Cyclophosphamide + Vinorelbine10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 98% Confidence Interval
GroupValueSpreadLowerUpperComment
Ramucirumab + Cyclophosphamide + VinorelbineNANot reportedNANAThe posterior median = 5.69, 98% credible interval (3.20 to 10.01)
Cyclophosphamide + VinorelbineNANot reportedNANAThe posterior median = 3.73, 98% credible interval (1.76 to 8.29)

Source statistical analyses

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

  1. ci Lower Limit
    0.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98
    ci Upper Limit
    1.69
    group Description
    The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The posterior probability treatment difference is 0.864
    param Type
    Posterior Mean Hazard Ratio
    param Value
    0.69
    statistical Method
    Bayesian hierarchical model
Complete source fields
analyses
  1. ci Lower Limit
    0.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98
    ci Upper Limit
    1.69
    group Description
    The Bayesian analyses below include posterior mean of Hazard ratio, and credible intervals instead of confidence intervals.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    The posterior probability treatment difference is 0.864
    param Type
    Posterior Mean Hazard Ratio
    param Value
    0.69
    statistical Method
    Bayesian hierarchical model
classes
  1. categories
    1. measurements
      1. comment
        The posterior median = 5.69, 98% credible interval (3.20 to 10.01)
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The posterior median = 3.73, 98% credible interval (1.76 to 8.29)
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      10
    units
    Participants
description
PFS was defined as the time from randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). The posterior median and 98% credible interval were estimated using Bayesian analysis. Data are presented as the posterior median with 98% credible interval.
dispersion Type
98% Confidence Interval
groups
  1. description
    Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
    id
    OG000
    title
    Ramucirumab + Cyclophosphamide + Vinorelbine
  2. description
    Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
    id
    OG001
    title
    Cyclophosphamide + Vinorelbine
param Type
MEDIAN
population Description
All randomized participants who received at least one dose of study drug (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 4, Cyclophosphamide + Vinorelbine = 2.
reporting Status
POSTED
time Frame
Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice